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
10 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-0584-2025
BELSOMRA
Manufacturer / Recalling Firm: Merck & Co. Inc
Reason for Recall: Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Affected Product Description
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)
Lots / Batch Codes & Expiration Dates
Lots 2090019 and 2123744, Exp. 4/30/2027
Distribution Scope
Nationwide in the USA and PR.
Class II (Moderate Risk)
Drug recall
Recall #: D-0579-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Affected Product Description
Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-165-05
Lots / Batch Codes & Expiration Dates
Lot#:19243104, Expires: 7/31/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0581-2025
METOPROLOL TARTRATE
Manufacturer / Recalling Firm: Westminster Pharmaceuticals LLC
Reason for Recall: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Affected Product Description
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
Lots / Batch Codes & Expiration Dates
Batch # R55230021, R55230031, R55230041, Exp Date: 9/30/25; Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025; Batch # R55230151, Exp Date: 11/30/25; Batch # R55240011, Exp Date: 12/31/25; Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date:...
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0582-2025
METOPROLOL TARTRATE
Manufacturer / Recalling Firm: Westminster Pharmaceuticals LLC
Reason for Recall: CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Affected Product Description
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-355-10
Lots / Batch Codes & Expiration Dates
Batch # R56240011, Exp Date: 2/28/26; Batch # R56240021, R56240031, Exp Date: 3/31/26; Batch # R56240041, R56240051, R56240061, Exp Date: 4/30/26; Batch # R56240071, Exp Date: 7/31/26
Distribution Scope
Nationwide in the USA.
Class II (Moderate Risk)
Drug recall
Recall #: D-0575-2025
LEVOXYL
Manufacturer / Recalling Firm: Pfizer
Reason for Recall: Subpotent drug
Affected Product Description
Levoxyl (levothyroxine sodium tablets, USP), 50 mcg, 100-count bottle, Rx only, Distributed by: Pfizer Inc., New York, NY 10017, Made in Austria, NDC 60793-851-01.
Lots / Batch Codes & Expiration Dates
Lot #: 24C11, Exp 2/28/2026.
Distribution Scope
Within U.S
Class II (Moderate Risk)
Drug recall
Recall #: D-0577-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Affected Product Description
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
Lots / Batch Codes & Expiration Dates
Lot#: a)19242274, 19242275, 19242272, Exp: 5/31/20; b) 19242272, Exp: 5/31/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0583-2025
THEOPHYLLINE
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do...
Affected Product Description
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Lots / Batch Codes & Expiration Dates
Batch # 19243193, 19243215, 19243231,19243248, 19243283, Exp 7/31/2026; 19244530, 19244561, Exp 10/31/2026; 19250178, Exp 12/31/2026
Distribution Scope
USA nationwide.
Class II (Moderate Risk)
Drug recall
Recall #: D-0576-2025
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Manufacturer / Recalling Firm: Ascend Laboratories, LLC
Reason for Recall: Failed Dissolution Specifications: low dissolution results
Affected Product Description
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/ 40 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-501-30
Lots / Batch Codes & Expiration Dates
Lot 23121560, Exp 4/30/2026
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0587-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Affected Product Description
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
Lots / Batch Codes & Expiration Dates
Lot #: 17241257, 17241258, 17241279, Exp. Date 06/2026
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0585-2025
LACTATED RINGERS
Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Affected Product Description
Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00.
Lots / Batch Codes & Expiration Dates
Lot #: J5C802, J5C917, J5C918, Exp. 08/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0588-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Affected Product Description
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
Lots / Batch Codes & Expiration Dates
Lot #: 17241213, 17241215, 17241224, Exp. Date 06/2026
Distribution Scope
Nationwide within the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0580-2025
DULOXETINE
Manufacturer / Recalling Firm: Breckenridge Pharmaceutical, Inc.
Reason for Recall: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Affected Product Description
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Lots / Batch Codes & Expiration Dates
Lot 240539C, Exp 1/31/2027
Distribution Scope
NJ, AZ, IN
Class II (Moderate Risk)
Drug recall
Recall #: D-0578-2025
CARVEDILOL
Manufacturer / Recalling Firm: Glenmark Pharmaceuticals Inc., USA
Reason for Recall: CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Affected Product Description
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
Lots / Batch Codes & Expiration Dates
Lot#:19243202, Exp: 7/31/2026.
Distribution Scope
Nationwide in the USA
Class II (Moderate Risk)
Drug recall
Recall #: D-0586-2025
SODIUM CHLORIDE
Manufacturer / Recalling Firm: B BRAUN MEDICAL INC
Reason for Recall: Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Affected Product Description
0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, Sterile, nonpyrogenic, single dose container, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7800-00.
Lots / Batch Codes & Expiration Dates
Lot #: J5C919, Exp. 08/31/2027
Distribution Scope
Nationwide in the US
Class II (Moderate Risk)
Drug recall
Recall #: D-0568-2025
Duloxetine D/R
Manufacturer / Recalling Firm: Direct Rx
Reason for Recall: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Affected Product Description
Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037,
Lots / Batch Codes & Expiration Dates
Lot #: a) 15AU2420, 01JY2407, 04OC2411, Exp 01/31/2027; 12SE2418, 24OC2424, 20NO2416, Exp 03/31/2027; 21AU2313, 21JY2311, 05JY2313, Exp Date 01/31/2026 b) 13OC2310, 05SE2304, 04AU2306, 21JY2317, 12JY2306, Exp 01/31/2026; 11JY2416, 28JU2414, 19AU2412, 02AU2409, Exp 01/31/2027; 11SE2416, 24OC2425, Exp 03/31/2027; c) 23AU2317, 21AU2314, Exp 01/31/20...
Distribution Scope
Nationwide
Class II (Moderate Risk)
Drug recall
Recall #: D-0559-2025
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0571-2025
XOLAIR
Manufacturer / Recalling Firm: Cardinal Health Inc.
Reason for Recall: CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Affected Product Description
Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.
Lots / Batch Codes & Expiration Dates
Lot: 3617756, Expires: 12/31/2025.
Distribution Scope
Nationwide Within the U.S.
Class II (Moderate Risk)
Drug recall
Recall #: D-0557-2025
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0565-2025
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA
Class II (Moderate Risk)
Drug recall
Recall #: D-0556-2025
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Manufacturer / Recalling Firm: AEQUITA PHARMACY
Reason for Recall: Lack of Processing Controls.
Affected Product Description
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
Lots / Batch Codes & Expiration Dates
All Lots within expiry.
Distribution Scope
MA