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
1 hour 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-0151-2026
Amoxicillin and Clavulanate Potassium for Oral Suspension USP
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: Subpotent drug; Clavulanate Potassium component
Affected Product Description
Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.
Lots / Batch Codes & Expiration Dates
Lot # 100062316, Exp Date: 01/2026
Distribution Scope
Distributed in three (3) States: MS, OH, CA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0110-2026
DESIPRAMINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Heritage Pharmaceuticals Inc
Reason for Recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Affected Product Description
Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Lots / Batch Codes & Expiration Dates
Lot#: 18036662, Exp. Date: 07/31/2026 Lot#: 18037649, Exp. Date: 03/31/2027
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0146-2026
LISDEXAMFETAMINE DIMESYLATE
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-048-88.
Lots / Batch Codes & Expiration Dates
Lot #: AD42470, Expiry: 2/28/2026; AD48708, Expiry:4/30/2026.
Distribution Scope
U.S Nationwide.
Class III (Low Risk)
Drug recall
Recall #: D-0139-2026
EVEROLIMUS
Manufacturer / Recalling Firm: Endo USA, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Affected Product Description
Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-125-91
Lots / Batch Codes & Expiration Dates
Lot #: 550184901, 550185001, Exp. Date MAR-26; 550189901, 550190001, Exp. Date APR-26 550203901, 550205601, Exp. Date Jul-26
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0126-2026
Testosterone 87.5 MG
Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
Affected Product Description
Testosterone 87.5 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0386-01
Lots / Batch Codes & Expiration Dates
Lot 3193, Exp 2/17/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall
Recall #: D-0147-2026
LISDEXAMFETAMINE DIMESYLATE
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.
Lots / Batch Codes & Expiration Dates
Lot #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026.
Distribution Scope
U.S Nationwide.
Class III (Low Risk)
Drug recall
Recall #: D-0141-2026
EVEROLIMUS
Manufacturer / Recalling Firm: Endo USA, Inc.
Reason for Recall: Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
Affected Product Description
Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each), Rx only, Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC# 49884-128-91
Lots / Batch Codes & Expiration Dates
Lot #: 550162801, Exp. Date NOV-25; 550169801, Exp. Date JAN-26
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0100-2026
DULOXETINE
Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Affected Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Lots / Batch Codes & Expiration Dates
90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0144-2026
LISDEXAMFETAMINE DIMESYLATE
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.
Lots / Batch Codes & Expiration Dates
Lot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026.
Distribution Scope
U.S Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0106-2026
PRAZOSIN HYDROCHLORIDE
Manufacturer / Recalling Firm: Teva Pharmaceuticals USA, Inc
Reason for Recall: CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Affected Product Description
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05
Lots / Batch Codes & Expiration Dates
a) NDC 0093-4069-01: Lot # 3010403A, 3010385A, 3010404A, Exp Date: 02/2026; Lot # 3010405A, 3010510A, 3010528A, 3010354A, Exp Date: 03/2026; Lot # 3010592A, 3010605A, 3010611A, 3010612A, Exp Date: 08/2026; Lot # 3010655A, 3010703A, Exp Date: 02/2027 b) NDC 0093-4069-52: Lot # 3010430A, Exp Date: 11/2025, Lot # 3010613A, Exp Date: 08/2026 c) NDC 0...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0129-2026
Testosterone Regular Release 200 MG
Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
Affected Product Description
Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0402-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: 3201, Exp 2/7/2026; 3202, Exp 2/21/2026; 3280, Exp 4/8/2026; 3283, Exp /9/2026.
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall
Recall #: D-0145-2026
LISDEXAMFETAMINE DIMESYLATE
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-047-88.
Lots / Batch Codes & Expiration Dates
Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.
Distribution Scope
U.S Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0113-2026
R.E.C.K.
Manufacturer / Recalling Firm: QuVa Pharma, Inc.
Reason for Recall: Presence of Particulate Matter
Affected Product Description
R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Tromethamine) in Sodium Chloride Solution, Total Volume: 50 mL syringe. INJECTION FOR PERIARTICULAR USE; Not for IV Use. THIS IS A COMPOUNDED DRUG. QuVA Pharma, 1075 West Park One Drive, Suite 100, Sugar Land, TX 77478. NDC 70092-1433-50
Lots / Batch Codes & Expiration Dates
Lot, expiry: 10149179 , exp 10/15/2025 ; 10149503 , exp 10/13/2025 ; 10149504 , exp 10/13/2025 ; 10149657 , exp 10/16/2025 ; 10149658 , exp 10/16/2025 ; 10149659 , exp 10/15/2025 ; 10150137 , exp 10/23/2025 ; 10150138 , exp 10/23/2025 ; 10150139 , exp 10/23/2025 ; 10150140 , exp 10/23/2025 ; 10149729 , exp 10/16/2025 ; 10149730 , exp 10/...
Distribution Scope
U.S. Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0134-2026
Testosterone / Triamcinolone Acetonide
Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
Affected Product Description
Testosterone / Triamcinolone Acetonide, 62.5MG/12.5MCG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0366-01
Lots / Batch Codes & Expiration Dates
Lot: 3090, Exp 1/7/2026; 3181, Exp 2/11/2026; 3189, 3190, Exp 2/12/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall
Recall #: D-0111-2026
DESIPRAMINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Heritage Pharmaceuticals Inc
Reason for Recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Affected Product Description
Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Lots / Batch Codes & Expiration Dates
Lot#: 18035574, Exp. Date 10/31/2025 Lot#: 18036758, Exp. Date 08/31/2026
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0109-2026
DESIPRAMINE HYDROCHLORIDE
Manufacturer / Recalling Firm: Heritage Pharmaceuticals Inc
Reason for Recall: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
Affected Product Description
Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, India, Manufactured for: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816.
Lots / Batch Codes & Expiration Dates
Lot#:18036713, Exp Date: 08/31/2026
Distribution Scope
U.S. Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0127-2026
Testosterone 200 MG
Manufacturer / Recalling Firm: FARMAKEIO OUTSOURCING LLC
Reason for Recall: CGMP Deviations: Potential presence of metal particulate matter
Affected Product Description
Testosterone 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball Ave, Ste 100, Southlake, TX 76092. NDC 73693-0381-01
Lots / Batch Codes & Expiration Dates
Lot, expiry: Lot 3203, exp 2/17/2026; Lot 3284, exp 4/8/2026
Distribution Scope
Nationwide in the USA and Antigua
Class II (Moderate Risk)
Drug recall
Recall #: D-0101-2026
PRAZOSIN HYDROCHLORIDE
Manufacturer / Recalling Firm: Amerisource Health Services LLC
Reason for Recall: Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Affected Product Description
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-996-01. Individual unit dose: NDC 68084-996-11
Lots / Batch Codes & Expiration Dates
Lot #: 1023526, 1023555, Expiry: 07/31/2026
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0122-2026
Sting Relief Swabs
Manufacturer / Recalling Firm: ACME UNITED CORPORATION
Reason for Recall: Product Mix-up
Affected Product Description
Sting Relief Swabs, First Aid Only, 10 Swabs per box, part number 19-001, Manufactured for: Acme United Corporation, 1 Waterview Dr. Shelton, CT, Made in the USA UPC 738743190015
Lots / Batch Codes & Expiration Dates
Lot #: 2251994, Exp 9/30/2029
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0150-2026
LISDEXAMFETAMINE DIMESYLATE
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
Affected Product Description
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-052-88.
Lots / Batch Codes & Expiration Dates
Lot #: AD48712, Expiry: 4/30/2026; AD50898, Expiry: 5/31/2026.
Distribution Scope
U.S Nationwide.