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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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Drug Recall Ongoing Historical recordClass III

Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONTENT 6.7 g, Manufactured by: Cipla Ltd, Indore, SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-142-60.

by Cipla USA, Inc.

Reason: Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Recall initiated: July 24, 2025
Reported by FDA: August 27, 2025
Distribution: U.S. Nationwide.

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Drug Recall Ongoing Historical recordClass III

Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIELD Toothpaste for Sensitive Teeth, Fresh Mint, Net WT 3.4OZ (96.4g) Tube, 6 tubes x 2 inners, per case, Distributed by GSK Consumer Healthcare, Warren, NJ 07059. UPC 3 10158 35691 2

by Haleon US Holdings LLC

Reason: Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Recall initiated: August 5, 2025
Reported by FDA: August 27, 2025
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-6637-24. Case NDC: 00409-6637-14.

by PFIZER INC

Reason: Lack of Assurance of Sterility.
Recall initiated: August 4, 2025
Reported by FDA: August 27, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045, USA. NDC 0409-4933-05. Case: NDC 0409-4933-10.

by PFIZER INC

Reason: Lack of Assurance of Sterility.
Recall initiated: August 4, 2025
Reported by FDA: August 27, 2025
Distribution: U.S. Nationwide

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Drug Recall Ongoing Historical recordClass II

BZK Antiseptic Towelette, Sterile, For External Use Only, benzalkonium chloride 0.13%, Antiseptic, 100 towelettes per carton , For Professional use, Mfg by: Taizhou Kangping Medical, Taizhou, JiangSu, China, NDC: 71310-111-01

by Taizhou Kangping Medical Science And Technology Co., Ltd.

Reason: Lack of Assurance of Sterility.
Recall initiated: July 22, 2025
Reported by FDA: August 27, 2025
Distribution: NY

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Drug Recall Ongoing Historical recordClass II

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)

by Merck & Co. Inc

Reason: 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.
Recall initiated: July 21, 2025
Reported by FDA: August 20, 2025
Distribution: Nationwide in the USA and PR.

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Drug Recall Ongoing Historical recordClass II

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

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

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

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

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Drug Recall Ongoing Historical recordClass II

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

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

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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

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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

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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

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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

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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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Data last updated: October 30, 2026 ET

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.