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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 II

Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-048-01

by Zydus Pharmaceuticals (USA) Inc

Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Recall initiated: September 3, 2025
Reported by FDA: September 17, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 25 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1130-1

by Zydus Pharmaceuticals (USA) Inc

Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Recall initiated: September 3, 2025
Reported by FDA: September 17, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01

by Zydus Pharmaceuticals (USA) Inc

Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Recall initiated: September 3, 2025
Reported by FDA: September 17, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534. NDC: 70710-1129-1

by Zydus Pharmaceuticals (USA) Inc

Reason: CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Recall initiated: September 3, 2025
Reported by FDA: September 17, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Neuroquell & Neuroquell Plus, .22 fl. Oz (6.6mL),Mfg. For/Dist. By Claire Ellen Products, P.O. Box 901 Westboro, MA 01581 USA, NDC 66233712-01

by Atlantic Management Resources Ltd.

Reason: cGMP violations
Recall initiated: August 27, 2025
Reported by FDA: September 17, 2025
Distribution: Product was distributed via the internet.

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Drug Recall Ongoing Historical recordClass II

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 0781-6186-67

by Sandoz Inc

Reason: Temperature Abuse
Recall initiated: August 13, 2025
Reported by FDA: September 17, 2025
Distribution: Product was distributed to one consignee in CA.

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Drug Recall Ongoing Historical recordClass II

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing NDC 0904-2725-61 (Inner blisters).

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated: September 2, 2025
Reported by FDA: September 17, 2025
Distribution: USA Nationwide.

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Drug Recall Ongoing Historical recordClass II

Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-2725-61

by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated: September 2, 2025
Reported by FDA: September 17, 2025
Distribution: USA Nationwide.

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Drug Recall Ongoing Historical recordClass II

Succinylcholine Chloride Injection, USP 200 mg/10 mL (20 mg/mL), Rx only, 10 mL Multiple-dose Vial, Sterile, Manufactured by Zydus Lifesciences Ltd, Vadodara, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1377-1 (vial), NDC 70710-1377-2 (carton).

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Recall initiated: August 27, 2025
Reported by FDA: September 17, 2025
Distribution: MS, OH, LA, and Puerto Rico

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Drug Recall Ongoing Historical recordClass II

Iodo Blanco Iodides, First Aid Antiseptic, Mercury Free, Iodine 2%, First Aid Antiseptic, Contains 1 fl. oz (30 ml) per bottle, Distributed by: Essential Products, www.essentialproductsusa.com, NDC: 70242-109-01

by World Perfumes Inc.

Reason: Defective Container: broken or leaking bottles.
Recall initiated: February 13, 2025
Reported by FDA: September 17, 2025
Distribution: FL

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Drug Recall Ongoing Historical recordClass II

Duloxetine Delayed-Release Capsules, USP, 30 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: 82009-030-10

by Breckenridge Pharmaceutical, Inc.

Reason: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Recall initiated: August 8, 2025
Reported by FDA: September 17, 2025
Distribution: AZ, IN, NJ

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Drug Recall Ongoing Historical recordClass II

4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10 mL (0.5 mEq/mL), For Intravenous Use Only, 10 mL Single Dose Vial, Rx Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645 USA, NDC 51754-5012-1 (vial); 51754-5012-4 (carton)

by Exela Pharma Sciences LLC

Reason: Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Recall initiated: July 30, 2025
Reported by FDA: September 17, 2025
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7800-09

by B BRAUN MEDICAL INC

Reason: Presence of Particulate Matter.
Recall initiated: August 18, 2025
Reported by FDA: September 10, 2025
Distribution: U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass I

Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07

by B BRAUN MEDICAL INC

Reason: Presence of Particulate Matter
Recall initiated: August 18, 2025
Reported by FDA: September 10, 2025
Distribution: U.S.A. Nationwide

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100-count bottles Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1062-1.

by Amneal Pharmaceuticals, LLC

Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated: August 18, 2025
Reported by FDA: September 10, 2025
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.

by Amneal Pharmaceuticals, LLC

Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated: August 18, 2025
Reported by FDA: September 10, 2025
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1058-1.

by Amneal Pharmaceuticals, LLC

Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated: August 18, 2025
Reported by FDA: September 10, 2025
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.

by Amneal Pharmaceuticals, LLC

Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated: August 18, 2025
Reported by FDA: September 10, 2025
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg, Double Strength, Rx Only, Packaged as a) 100-count bottle, NDC 65162-272-10; b) 500-count bottle, NDC 65162-272-50; Manufactured by: Amneal Pharmaceuticals, Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad, 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807.

by Amneal Pharmaceuticals, LLC

Reason: Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Recall initiated: August 18, 2025
Reported by FDA: September 10, 2025
Distribution: Distributed Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusion After Dilution, Single-Does vial. Mfd by: Immunocore Limited, 92 Park Drive, Abingdon, Oxfordshire, OX14 4RY, United Kingdom, For: Immunocore Commercial LLC, 181 Washington St, Conshohocken, PA, 19428, Product of Denmark NDC 80446-0401-01 Lot #: 3D009AA09, 3D009AA10, 3D009AA25, Exp Date: 31 MAR 2026 NDC 80446-0401-99 (Non-Commercial FG) Lot #: 3D009AA02, Exp Date 31 MAR 2026

by IMMUNOCORE, LLC

Reason: Subpotent Drug
Recall initiated: June 10, 2025
Reported by FDA: September 10, 2025
Distribution: US 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.