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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 I

Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.

by Aurobindo Pharma USA Inc

Reason: Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Recall initiated: July 11, 2024
Reported by FDA: August 28, 2024
Distribution: NJ, NY & PA

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Drug Recall Completed Historical recordClass II

HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210

by Zeco LLC

Reason: CGMP Deviations: sterile water not used for production
Recall initiated: August 5, 2024
Reported by FDA: August 28, 2024
Distribution: Nationwide within the United States and Toronto, Canada (Rubbing alcohol)

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Drug Recall Completed Historical recordClass II

Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.

by Zeco LLC

Reason: CGMP Deviations: sterile water not used for production
Recall initiated: August 5, 2024
Reported by FDA: August 28, 2024
Distribution: Nationwide within the United States and Toronto, Canada (Rubbing alcohol)

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Drug Recall Ongoing Historical recordClass I

0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

by B. Braun Medical Inc

Reason: Presence of Particulate Matter
Recall initiated: July 24, 2024
Reported by FDA: August 28, 2024
Distribution: Nationwide within U.S.A

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Drug Recall Ongoing Historical recordClass II

Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30

by Teva Pharmaceuticals USA, Inc

Reason: Superpotent Drug
Recall initiated: August 8, 2024
Reported by FDA: August 28, 2024
Distribution: Product was distributed nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.

by Fagron Compounding Services

Reason: Lack of Assurance of Sterility
Recall initiated: August 15, 2024
Reported by FDA: August 28, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01

by Hikma Pharmaceuticals USA Inc.

Reason: Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
Recall initiated: July 8, 2024
Reported by FDA: August 28, 2024
Distribution: OH and PR

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Drug Recall Completed Historical recordClass III

Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01

by Taro Pharmaceuticals U.S.A., Inc.

Reason: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Recall initiated: August 7, 2024
Reported by FDA: August 21, 2024
Distribution: Product was distributed to one distributor

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Drug Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05].

by FDC Limited

Reason: Defective container; yellow colored spike from cap lodged in the nozzle
Recall initiated: July 18, 2024
Reported by FDA: August 21, 2024
Distribution: Nationwide in the US

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Drug Recall Terminated Historical recordClass II

Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05

by Granules Pharmaceuticals Inc.

Reason: Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
Recall initiated: July 31, 2024
Reported by FDA: August 14, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2

by A-S Medication Solutions LLC

Reason: Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
Recall initiated: June 21, 2024
Reported by FDA: August 14, 2024
Distribution: Nationwide within the United States.

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Drug Recall Terminated Historical recordClass II

Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064

by EMPOWER CLINIC SERVICES LLC

Reason: Lack of Assurance of Sterility
Recall initiated: August 2, 2024
Reported by FDA: August 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Completed Historical recordClass III

Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1

by Amneal Pharmaceuticals, LLC

Reason: Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Recall initiated: August 1, 2024
Reported by FDA: August 14, 2024
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.

by Novel Laboratories, Inc. d.b.a Lupin Somerset

Reason: Defective container: potential for non-sealed pouches which can lead to product leakage.
Recall initiated: July 2, 2024
Reported by FDA: August 14, 2024
Distribution: Nationwide in the US.

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Drug Recall Terminated Historical recordClass III

Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India

by Granules Consumer Health Inc.

Reason: Label mix-up: Carton incorrectly labeled.
Recall initiated: July 18, 2024
Reported by FDA: August 14, 2024
Distribution: Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.

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Drug Recall Ongoing Historical recordClass I

Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.

by MAIN PRODUCTS INC

Reason: Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Recall initiated: July 18, 2024
Reported by FDA: August 14, 2024
Distribution: Nationwide within the U.S

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Drug Recall Ongoing Historical recordClass III

Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90

by Dr. Reddy's Laboratories, Inc.

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Recall initiated: June 26, 2024
Reported by FDA: August 14, 2024
Distribution: Nationwide within the United States

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Drug Recall Ongoing Historical recordClass II

Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC 55150-306-10.

by Eugia US LLC

Reason: Presence of Particulate Matter: Complaint received of a glass particle in the vial.
Recall initiated: July 26, 2024
Reported by FDA: August 7, 2024
Distribution: Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.

by FDC Limited

Reason: Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Recall initiated: July 23, 2024
Reported by FDA: August 7, 2024
Distribution: U.S. A. Nationwide

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Drug Recall Terminated Historical recordClass I

Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.

by Endo Pharmaceuticals, Inc.

Reason: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Recall initiated: July 10, 2024
Reported by FDA: August 7, 2024
Distribution: Nationwide in the USA and Puerto Rico

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Data last updated: October 31, 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.