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
8 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-0781-2026
LEVOTHYROXINE SODIUM
Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
Affected Product Description
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17.
Lots / Batch Codes & Expiration Dates
Lot #: D2401983, Exp. Date 08/31/2026; D2402640, D2402641, Exp. Date 11/30/2026; D2500224, Exp. Date 01/31/2027.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0776-2026
LEVOTHYROXINE SODIUM
Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
Affected Product Description
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
Lots / Batch Codes & Expiration Dates
Lot #: D2401834, D2401982, Exp. Date 08/31/2026; D2402584, D2402585, D2402586, D2402588, D2402587, D2402589, Exp Date. 11/30/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0831-2026
RAMIPRIL
Manufacturer / Recalling Firm: Hikma Pharmaceuticals USA INC.
Reason for Recall: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Affected Product Description
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
Lots / Batch Codes & Expiration Dates
a) Lot #: AC5470A, Exp. Date July 2027 b) Lot #: AC5470B, Exp. Date July 2027
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0785-2026
LEVOTHYROXINE SODIUM
Manufacturer / Recalling Firm: ACCORD HEALTHCARE, INC.
Reason for Recall: Subpotent Drug
Affected Product Description
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
Lots / Batch Codes & Expiration Dates
a) Lot # D2402430, D2402431, Exp Date: 10/31/2026. b) Lot #: D2402432, Exp. Date 10/31/2026; D2500180, Exp. Date 12/31/2026.
Distribution Scope
Nationwide within the United States
Class II (Moderate Risk)
Drug recall
Recall #: D-0801-2026
TRALEMENT
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Affected Product Description
Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 25149, Exp. Date: 04/30/2027; 25371, Exp. Date: 09/30/2027.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0792-2026
CYANOCOBALAMIN
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Affected Product Description
Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 24297, Exp. Date 8/31/2026; 24364, Exp. Date: 10/31/2026;
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0770-2026
Carbamazepine Tablets
Manufacturer / Recalling Firm: SUN PHARMACEUTICAL INDUSTRIES INC
Reason for Recall: CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
Affected Product Description
Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC 51672-4005-3.
Lots / Batch Codes & Expiration Dates
Lot # AD94033, Exp Date: 5/31/2028.
Distribution Scope
US Nationwide.
Class I (High Risk)
Drug recall
Recall #: D-0788-2026
MORPHINE SULFATE
Manufacturer / Recalling Firm: Fresenius Kabi USA, LLC
Reason for Recall: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
Affected Product Description
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sale NDC Number 76045-004-11
Lots / Batch Codes & Expiration Dates
Lot #: 6402820, Exp. Date 12/2028
Distribution Scope
Nationwide within the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0798-2026
SELENIOUS ACID
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Affected Product Description
Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 25090, Exp. Date 2/28/2027.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0794-2026
AMINOCAPROIC ACID
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Affected Product Description
AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 24299, Exp. Date: 8/31/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0802-2026
NICARDIPINE HYDROCHLORIDE
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Affected Product Description
niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
Lots / Batch Codes & Expiration Dates
Lot #: 25295N0C0, Exp. Date: 04/30/2027.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0765-2026
PEMRYDI RTU
Manufacturer / Recalling Firm: Shilpa Medicare Limited
Reason for Recall: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Affected Product Description
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
Lots / Batch Codes & Expiration Dates
Lot: P400157, Exp 08/31/2026; Lot PA00047A, Exp 09/30/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0774-2026
ACAMPROSATE CALCIUM
Manufacturer / Recalling Firm: Mylan Pharmaceuticals Inc
Reason for Recall: Failed Dissolution Specifications
Affected Product Description
Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.
Lots / Batch Codes & Expiration Dates
Lot# 3227809; Expiry:10/2026; NDC #: 0378-6333-80
Distribution Scope
US Nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0791-2026
NITROGLYCERIN
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Affected Product Description
Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 24291, Exp. Date: 8/31/2026
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0767-2026
LIBTAYO
Manufacturer / Recalling Firm: Regeneron Pharmaceuticals Inc
Reason for Recall: Lack of Assurance of Sterility
Affected Product Description
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
Lots / Batch Codes & Expiration Dates
Lot: 8494000002, Exp 7/31/28
Distribution Scope
USA Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0795-2026
ATROPINE SULFATE
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Affected Product Description
Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 24353, Exp. Date: 9/30/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0764-2026
PEMRYDI RTU
Manufacturer / Recalling Firm: Shilpa Medicare Limited
Reason for Recall: Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Affected Product Description
PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2453-1
Lots / Batch Codes & Expiration Dates
Lot: P400172; Lot PA00050A, Exp 09/30/2027
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0796-2026
ACETYLCYSTEINE
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Affected Product Description
ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 24418, Exp. Date: 11/30/2026; 25131, Exp. Date: 3/31/2027; 25349, Exp. Date: 8/31/2027
Distribution Scope
Nationwide within the U.S
Class I (High Risk)
Drug recall
Recall #: D-0800-2026
PAPAVERINE HYDROCHLORIDE
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
Affected Product Description
Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 25202, Exp. Date: 11/30/2026.
Distribution Scope
Nationwide within the U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0797-2026
ACETYLCYSTEINE
Manufacturer / Recalling Firm: American Regent, Inc.
Reason for Recall: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Affected Product Description
ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Lots / Batch Codes & Expiration Dates
Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.
Distribution Scope
Nationwide within the U.S