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 hours ago
Total FDA Recalls
1,170
Active / Ongoing
1,133
Critical (Class I)
63
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 II (Moderate Risk)
Drug recall
Recall #: D-0408-2026
traMADol Hydrochloride Tablets
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.
Class III (Low Risk)
Drug recall
Recall #: D-0391-2026
PITAVASTATIN CALCIUM
Manufacturer / Recalling Firm: Annora Pharma Private Limited
Reason for Recall: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Affected Product Description
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
Lots / Batch Codes & Expiration Dates
Lot #: A252487, Exp 05/31/2027
Distribution Scope
TN
Class II (Moderate Risk)
Drug recall
Recall #: D-0390-2026
IBUPROFEN
Manufacturer / Recalling Firm: STRIDES PHARMA INC
Reason for Recall: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Affected Product Description
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Lots / Batch Codes & Expiration Dates
Lot: 7261973A, 7261974A, Exp 01/31/2027
Distribution Scope
U.S.A. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0407-2026
BRIMONIDINE TARTRATE/TIMOLOL MALEATE OPHTHALMIC SOLUTION
Manufacturer / Recalling Firm: Apotex Corp.
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
Lots / Batch Codes & Expiration Dates
Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0400-2026
ICOSAPENT ETHYL
Manufacturer / Recalling Firm: Zydus Pharmaceuticals (USA) Inc
Reason for Recall: Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Affected Product Description
Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1592-7
Lots / Batch Codes & Expiration Dates
Lot #: S2520249, S2520250, S2520267, Exp. Date 2027/Jan; S2520303, S2520305, S2520332, Exp. Date 2027/Feb; S2540208, S2540209, Exp. Date 2027/Apr
Distribution Scope
Nationwide in the USA
Class I (High Risk)
Drug recall
Recall #: D-0388-2026
SILINTAN 25/pills
Manufacturer / Recalling Firm: ANTHONY TRINH, 123Herbals LLC
Reason for Recall: Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Affected Product Description
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Lots / Batch Codes & Expiration Dates
All lots within expiry
Distribution Scope
USA nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0377-2026
Children's Healthcare of Atlanta
Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
Affected Product Description
Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00
Lots / Batch Codes & Expiration Dates
Lot #: MN12122, Exp. Date Apr 2027; MN27523, Exp. Date Aug 2028; MN30922, Exp. Date Oct 2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0356-2026
METOPROLOL SUCCINATE
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.
Lots / Batch Codes & Expiration Dates
Lot#: a) 0718J251, 0729J251, 0730J251, Exp.: 12/2026; b) 0718J252, 0729J252, 0730J252, Exp.: 12/2026.
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0362-2026
1) BZK Antiseptic Towelettes
Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
Affected Product Description
1) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5"x7" Piedmont Sanitizing Hand Wipes, 1,000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 2) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Touchpoint, 1000 ea Bulk, Made in USA for : Food Service Resources, Flowery Branch, GA 30542. NDC 0924-7130-00. 3) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" Wellstar Cobb Hand Wipes, 1000 ea Bulk, Made in the USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. 4) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x 7" FSR Sanitizing Hand Wipes, 1000 ea Bulk, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00. Inner Packaging - Instant Hand Sanitizing Wipes 5) BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 5" x7" Children's 1000 ea Bulk, Made in USA for: Food Service Resources, Flowery Branch, GA 30542 NDC 0924-713-00. Inner packaging -Children's Healthcare of Atlanta
Lots / Batch Codes & Expiration Dates
1) Lot #: MN22222, Exp. Date Jul 2027; MN05523, Exp. Date Jan 2028; MN32023, Exp. Date Oct 2028; MN15523, Exp. Date May 2028. 2) Lots MN11422B, MN11422, Exp. Date Mar 2027; MN03823, Exp. Date Jan 2028; MN09223 Exp. Date Mar 2028; MN32123, Exp. Date Oct 2028; MN20323, Exp. Date Jun 2028; MN30822 Exp. Date Oct 2027; MN304024, Exp. Date Dec 2028; M...
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0372-2026
WP WipesPlus Hand Sanitizing Wipes
Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: CGMP Deviations
Affected Product Description
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.
Lots / Batch Codes & Expiration Dates
Lot #: MN27922, MN21722, MN21822, Exp. Date Jul 2027; MN27422, MN27522, Exp. Date Sep 2027; MN25422, Exp. Date Aug 2027; MN27922, MN27922, Exp. Date Sep 2027.
Distribution Scope
Nationwide within the United States