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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 861–880 of 17,898 drug recalls

Drug Recall Ongoing Historical recordClass II

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

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Recall initiated
August 6, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide within the USA

View recall →

Drug Recall Ongoing Historical recordClass II

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.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Recall initiated
August 4, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide in the US

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Drug Recall Ongoing Historical recordClass II

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.

by B BRAUN MEDICAL INC

Reason
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Recall initiated
August 4, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Glenmark Pharmaceuticals Inc., USA

Reason
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 not comply with L3 stage dissolution criteria.
Recall initiated
August 8, 2025
Reported by FDA
August 20, 2025
Distribution
USA nationwide.

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Drug Recall Ongoing Historical recordClass II

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

by Westminster Pharmaceuticals LLC

Reason
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Recall initiated
August 6, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

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

by Breckenridge Pharmaceutical, Inc.

Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Recall initiated
July 25, 2025
Reported by FDA
August 20, 2025
Distribution
NJ, AZ, IN

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Drug Recall Ongoing Historical recordClass II

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

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Recall initiated
August 7, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

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.

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Recall initiated
August 7, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

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

by Ascend Laboratories, LLC

Reason
Failed Dissolution Specifications: low dissolution results
Recall initiated
July 21, 2025
Reported by FDA
August 20, 2025
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

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.

by Pfizer

Reason
Subpotent drug
Recall initiated
July 29, 2025
Reported by FDA
August 20, 2025
Distribution
Within U.S

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Drug Recall Ongoing Historical recordClass II

Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St, Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-143-01

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Presence of foreign substance: identified as aluminum.
Recall initiated
August 5, 2025
Reported by FDA
August 13, 2025
Distribution
USA Nationwide

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Drug Recall Ongoing Historical recordClass II

RECOMBINATE, [Antihemophilic Factor (Recombinant)], 5 mL vials, Rx Only, Takeda Pharmaceuticals USA, Cambridge, MA 02142, NDC: 00944-2843-01

by Cardinal Health Inc.

Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall initiated
July 30, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide Within the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South San Francisco, CA 94080, NDC 50242-214-55

by Cardinal Health Inc.

Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall initiated
July 30, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide Within the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 50242-215-55.

by Cardinal Health Inc.

Reason
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Recall initiated
July 30, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide Within the U.S.

View recall →

Drug Recall Ongoing Historical recordClass II

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,

by Direct Rx

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated
March 7, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

by Direct Rx

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated
March 7, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass II

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31

by Alembic Pharmaceuticals Limited

Reason
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recall initiated
July 25, 2025
Reported by FDA
August 13, 2025
Distribution
Nationwide in the USA.

View recall →

Drug Recall Ongoing Historical recordClass II

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.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide + Cyanocobalamin injection solution, 2.21 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.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Drug Recall Ongoing Historical recordClass II

Semaglutide +Cyanocobalamin 1.5 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.

by AEQUITA PHARMACY

Reason
Lack of Processing Controls.
Recall initiated
July 18, 2025
Reported by FDA
August 13, 2025
Distribution
MA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.