FDA Enforcement Database
Drug Safety & Recalls Center
Access structured drug recall and safety information sourced directly from the U.S. Food & Drug Administration (FDA) OpenFDA Enforcement API. Stay informed on active market withdrawals, manufacturing defect notices, and drug safety advisories.
Last Synchronized
2 weeks ago
Total FDA Recalls
999
Active / Ongoing
962
Critical (Class I)
45
Medical & Legal Disclaimer: The information on this page is compiled for informational and educational reference only and does not constitute medical advice or clinical diagnosis. Never discontinue, start, or substitute any medication without consulting your prescribing doctor or a licensed pharmacist. For urgent health concerns regarding a recalled product, contact your physician immediately or report adverse events to FDA MedWatch.
Latest Critical Safety Updates (Class I)
Recent FDA enforcement reports involving serious health risk classifications
Class I
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinib...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Ste...
Class I
CHLORAPREP ONE-STEP
Non-Sterility: Due to presence of Aspergillus penicillioides.
Class II (Moderate Risk)
Drug recall
Recall #: D-0410-2026
QUALITY CHOICE MOISTURIZING RELIEF EYE DROPS
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15 mL) bottles, Sterile; a) Walgreens, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015; UPC 3 11917 20074 3; b) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; c) CVS Health, Distributed by :CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 43544 1; d) QC-Quality Choice, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-191-14; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01155 9; f) Foster & Thrive, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, NDC 70677-1158-1; g) GoodSense, Distributed By: Perrigo Direct Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-130-01; h) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03641 3; I) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02556 3; j) Fast Acting, CODE RED Eye Drops, Sterile, Distributed by: 4 Trees, LLC, NDC 83817-963-01.
Lots / Batch Codes & Expiration Dates
Lot: a) AR24D01, Exp.: 04/30/26; AR24G01, AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; b) AR24D01, Exp.: 04/30/26; AR24G01, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; c) AR24D01, Exp.: 04/30/26; AR24G02, Exp.: 07/31/26; AR24M01, Exp.: 10/31/26; d) AR24G02, Exp.: 07/31/26; e) AR24G02, Exp.: 07/31/26; f) AR24G02, Exp.: 07/31/26; g) AR24M01, Exp.:...
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0421-2026
PRAZOSIN HYDROCHLORIDE
Manufacturer / Recalling Firm: Appco Pharma LLC
Reason for Recall: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Affected Product Description
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.
Lots / Batch Codes & Expiration Dates
Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0414-2026
GNP EYE DROPS REDNESS AND DRY EYE RELIEF
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%), 0.5 fl oz (15 mL) bottles; a) Industrial Eye Relief, Distributed by: Cintas Corp., Mason, OH 45040, UPC 130209; b) Good Neighbor Pharmacy Eye Drops, Redness & Dry Eye Relief, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-606-05; c) Colirio Ojo De Aguila Eye Drops, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01615 5; d) Colirio OFTAL-MYCIN, Distributed by: Grandall Distributing Co., Inc., Glendale, CA 91204-2707, UPC 3 48201 01613 1; e) LEADER Redness Relief, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0010-1; f) Equaline, sterile redness relief, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 46151 2; g) Walgreens, Redness Relief Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 17741 0; h) Foster & Thrive, Redness Relief Eye Drops, Sterile, Distributed by: McKesson Corp., via SSSL, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1161-1; i) LUBRICANT EYE DROPS, Redness Relief, DISTRIBUTEDBY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011, NDC 11822-6453-4; j) Discount drug mart, Eye Drops Redness Relief, Distributed by: Discount Drug Mart, Medina, OH 44256, UPC 0 93351 03411 4
Lots / Batch Codes & Expiration Dates
Lot: a) RL24D01, Exp.: 04/30/26; RL24F01, RL24F02, Exp.:06/30/26; b) RL24F01, RL24F02, Exp.:06/30/26; c) RL24F01, Exp.:06/30/26; d) RL24F02, Exp.:06/30/26; e) RL24F01, RL24F02, Exp.:06/30/26; f) RL24F01, RL24F02, Exp.:06/30/26; g) RL24F01, RL24F02, Exp.:06/30/26; h) RL24F01, Exp.:06/30/26; i) RL24F01, Exp.:06/30/26; j) RL24F02, Exp.:06/30/26; k)
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0411-2026
ARTIFICIAL TEARS
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene glycol 400 1%) 0.5 FL OZ (15 mL) bottles; a) GERI CARE, Distributed by: Gericare Pharmaceuticals Corp., Lakewood, NJ 08701, NDC 57896-181-05; b) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; c) Rite Aid, DISTRIBUTEDBY: RITE AID, Camp Hill, PA 17011, NDC 11822-1067-2; d) LEADER DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0502-1; e) Discount drug mart, Discount Drug Mart Food Fair, Medina, OH 44256, UPC 0 93351 01156 6; f) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; g) Foster & Thrive, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1158-1; h) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-718-01; i) DG health Sterile, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; j) Harris Teeter, Eye Drops, Artificial Tears, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71303 2; k) exchange select, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; l) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 46122-605-05
Lots / Batch Codes & Expiration Dates
Lot: a) LT24E01, LT24E02, LT24E03, Exp.: 05/31/26; LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; LT24M01, LT24M02, Exp.: 10/31/26; b) LT24E03, Exp.: 05/31/26; LT24F01, Exp.:06/30/26; LT24G01, Exp.:07/31/26; LT24M02, Exp.: 10/31/26; c) LT24F01, Exp.: 06/30/26; d) LT24F01, Exp.: 06/30/26; LT24G01, Exp.: 07/31/26; e) LT24F01, Exp.: 06/30/26; f) L...
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0413-2026
GOODSENSE EYE DROPS ORIGINAL FORMULA
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-141-01; b) Walgreens, Eye Drops, Original Formula, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20073 6; c) Walgreens, Eye Drops, Original Formula, 2 Bottles, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20076 7; d) Kroger Sterile eye drops, Original, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 1110 38597 0; e) Sterile eye drops, Regular formula, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, UPC 3 66715 68324 3; f) CVP Sterile EYE DROPS, Distributed by: Salado Sales. Inc., Temple, TX 76503; UPC 7 61606 16500 3; g) Harris Teeter, Eye Drops, Original, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 71302 5; h) H.E.B Original Eye Drops, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; i) Rugby tetrahydrozoline ophthalmic Solution, Distributed by: RUGBY LABORATORIES, IN 46268, NDC 0536-1217-94, j) Equaline, DISTRIBUTED BY UNFI, PROVIDENCE, RI 02908, UPC 0 41163 25110 6; k) Discount drug mart, EyeDrops ORIGINAL, Discount Drug Mart Food Fair, 211 Commerce Drive, Medina, OH 44256, UPC 0 93351 01156 3; L) LEADER Original Eye Drops, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0454-1; m) CAREone, DISTRIBUTED BY FOODHOLD U.S.A, LLC, LANDOVER, MD 20785, NDC 41520-431-05; n) Circle K sterile eye drops, Product manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404, Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; o) DG health Original Formula, DISTRIBUTED BY OLD EAST MAIN CO., GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; p) Good Neighbor Pharmacy Eye Drops, Original Formula, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-075-05; q) TopCare health, Original Eye Drops, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; r) Best Choice, Eye Drops, ORIGINAL, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47011 3
Lots / Batch Codes & Expiration Dates
Lot: a) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; b) RG24E01, Exp.: 05/31/26; RG24G02, Exp.: 07/31/26; c) RG24G02, Exp.: 07/31/26; d) RG24E01, Exp.: 05/31/26; RG24G01, RG24G02; Exp.: 07/31/26; e) RG24E01, Exp.: 05/31/26; RG24G01, Exp.: 07/31/26; f) RG24E01, Exp.: 05/31/26; RG24G02; Exp.: 07/31/26; g) RG24E01, Exp.: 05/31/26; h) RG24E01, Exp...
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0412-2026
LEADER ULTRA LUBRICATING EYE DROPS
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0457-1; b) Harris Teeter, Eye Drops, Ultra Lubricant, PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC, MATHEWS, NC 28105, UPC 0 72036 73588 1; c) Foster & Thrive, Lubricating Eye Drops, Distributed by: McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141, www.fosterandthrive.com, NDC 70677-1160-1; d) Walgreens Lubricant Eye Drops, DISTRIBUTED BY: WALGREEN CO., DEERFIELD, IL 60015, UPC 3 11917 20167 2; e) P high performance Eye drops, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 09876 3; f) Kroger high performance lubricant eye drops, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202; g) Good Sense Ultra Lubricant Eye Drops, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-160-01; h) meijer Ultra Lubricant, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, www.meijer.com, NDC 41250-937-01; i) CVS Health, Fast Acting Lubricant Eye Drops, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, UPC 0 50428 39690 2; j) CVS Health, Fast Acting Lubricant Eye Drops, Twin pack, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 44738 3; k) QC-Quality Choice, Lubricant Eye Drops, Distributed by: CDMA, Inc., Novi, MI 48375, NDC 83324-029-15; l) AVENOVA LUBRICANT EYE DROPS, Twin pack, Distributed by: NovaBay Pharmaceuticals, Inc., CA 94608, UPC 8 57005 00411 9.
Lots / Batch Codes & Expiration Dates
Lot: a) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; b) SU24E01, Exp.: 5/31/26; c) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; d) SU24E01, SU24E02, Exp.: 5/31/26; e) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; f) SU24E01, SU24E02, Exp.: 5/31/26; SU24K01, Exp.: 9/30/26; g) SU24E01, SU24E02, SU24E03, Exp.: 5/31/2...
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0416-2026
LEADER ARTIFICIAL TEARS 15 ML
Manufacturer / Recalling Firm: K.C. Pharmaceuticals, Inc
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, www.myleader.com, NDC 70000-0011-1; b) Good Sense, Distributed By: Perrigo Direct, Inc., Peachtree City, GA 30269, www.PerrigoDirect.com, NDC 50804-110-01; c) Good Neighbor Pharmacy, Distributed By AmerisourceBergen, Conshohocken, PA 19428, NDC 24385-006-05; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 09331 7; e) Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., KANSAS CITY, KS 66106, UPC 0 70038 47008 3; f) Kroger, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202, UPC 0 11110 38600 7; g) P, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, LAKELAND, FL 33811, UPC 0 41415 00976 9; h) Quality Choice, Distributed by CDMA Inc, Novi, MI NDC 83324-189-14
Lots / Batch Codes & Expiration Dates
Lot: a) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; b) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; c) AT24D01, Exp.: 04/30/26; AT24E01, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; d) AT24D01, Exp.: 04/30/26; AT24E01, AT24E02, Exp.: 05/31/26; AT24G01, Exp.: 07/31/26; e) AT24E01, Exp...
Distribution Scope
Nationwide in the US
Class I (High Risk)
Drug recall
Recall #: D-0478-2026
MAGNESIUM SULFATE
Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Affected Product Description
Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further packaged in cartons of 12 x 100 mL IV bags, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad, 382110, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1720-3.
Lots / Batch Codes & Expiration Dates
Lot: AH250162, Exp 8/31/2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0420-2026
PRAZOSIN HYDROCHLORIDE
Manufacturer / Recalling Firm: Appco Pharma LLC
Reason for Recall: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Affected Product Description
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
Lots / Batch Codes & Expiration Dates
Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0408-2026
TRAMADOL HYDROCHLORIDE
Manufacturer / Recalling Firm: Amneal Pharmaceuticals, LLC
Reason for Recall: Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Affected Product Description
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.
Lots / Batch Codes & Expiration Dates
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0419-2026
PRAZOSIN HYDROCHLORIDE
Manufacturer / Recalling Firm: Appco Pharma LLC
Reason for Recall: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Affected Product Description
Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
Lots / Batch Codes & Expiration Dates
Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0402-2026
CUROSURF
Manufacturer / Recalling Firm: Chiesi USA, Inc.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Lots / Batch Codes & Expiration Dates
Lot #: 1213748, Exp. Date 09/2026; 1215076, 1215077, Exp. Date 10/26.
Distribution Scope
Nationwide within the United States
Class III (Low Risk)
Drug recall
Recall #: D-0401-2026
SODIUM IODIDE I-131
Manufacturer / Recalling Firm: Radnostix
Reason for Recall: Failed Tablet/Capsule Specifications
Affected Product Description
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 3666245, exp: 02/28/2026; Lot 4546213, exp: 02/28/2026 and Lot 4951280, exp 09/30/2027
Distribution Scope
Nationwide in the US, including Puerto Rico
Class II (Moderate Risk)
Drug recall
Recall #: D-0418-2026
MECLIZINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Failed tablet specifications.
Affected Product Description
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.
Lots / Batch Codes & Expiration Dates
Lot #1024852; Exp 9/30/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0406-2026
OCTREOTIDE ACETATE
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Affected Product Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9262-08.
Lots / Batch Codes & Expiration Dates
Lot:4400401, Exp.: 6/30/2026; 4401393, 4401494, 4401604, Exp.: 9/31/2026; 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006, Exp.: 3/31/2027.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0404-2026
OCTREOTIDE ACETATE
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Affected Product Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.
Lots / Batch Codes & Expiration Dates
Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0403-2026
LEVOTHYROXINE SODIUM
Manufacturer / Recalling Firm: MACLEODS PHARMA USA, INC
Reason for Recall: Subpotent Drug
Affected Product Description
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44
Lots / Batch Codes & Expiration Dates
Lot 16240062A, exp date 3/2026
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0405-2026
OCTREOTIDE ACETATE
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Affected Product Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.
Lots / Batch Codes & Expiration Dates
Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026; 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0398-2026
DEXAMETHASONE SODIUM PHOSPHATE
Manufacturer / Recalling Firm: SOMERSET THERAPEUTICS LLC
Reason for Recall: Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impu...
Affected Product Description
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
Lots / Batch Codes & Expiration Dates
Lot #: A240421, Exp 07/31/2026
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall
Recall #: D-0528-2026
Webcol Alcohol Prep pad
Manufacturer / Recalling Firm: Cardinal Health 200, LLC
Reason for Recall: Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Affected Product Description
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Lots / Batch Codes & Expiration Dates
Lot #: 25H065362; 25J013962; 25J034762; 25J064562; 25K004962; 25K041262; 25K065062; 25L015362; 25H065462; 25J014062; 25J035762; 25J064762; 25K005062; 25K041362; 25K065162; 25L015462; 25H066062; 25J014862; 25J035862; 25J064862; 25K006162; 25K041462; 25K065262; 25L015662; 25H066162; 25J014962; 25J035962; 25J064962; 25K006262; 25K041562; 25K065362...
Distribution Scope
Nationwide within the United States, Puerto Rico and Japan.