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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 1,501–1,520 of 17,937 drug recalls

Drug Recall Ongoing Historical recordClass II

Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01

by ProRx LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 22, 2024
Reported by FDA
September 11, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01

by ProRx LLC

Reason
Lack of Assurance of Sterility
Recall initiated
August 22, 2024
Reported by FDA
September 11, 2024
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass I

Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04

by Baxter Healthcare Corporation

Reason
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recall initiated
August 1, 2024
Reported by FDA
September 11, 2024
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01

by Lupin Pharmaceuticals Inc.

Reason
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Recall initiated
August 21, 2024
Reported by FDA
September 4, 2024
Distribution
USA nationwide.

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Drug Recall Ongoing Historical recordClass II

IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Recall initiated
August 6, 2024
Reported by FDA
September 4, 2024
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Ongoing Historical recordClass II

IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Recall initiated
August 6, 2024
Reported by FDA
September 4, 2024
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Ongoing Historical recordClass II

Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.

by Preferred Pharmaceuticals, Inc.

Reason
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Recall initiated
August 8, 2024
Reported by FDA
September 4, 2024
Distribution
CA and NV

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Drug Recall Ongoing Historical recordClass II

IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Recall initiated
August 6, 2024
Reported by FDA
September 4, 2024
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Ongoing Historical recordClass II

Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.

by Glenmark Pharmaceuticals Inc., USA

Reason
Failed Dissolution Specifications: below specification results
Recall initiated
July 31, 2024
Reported by FDA
September 4, 2024
Distribution
Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey

by FDC Limited

Reason
Defective Container: patients are 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
August 12, 2024
Reported by FDA
August 28, 2024
Distribution
Nationwide U.S.A.

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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

View recall →

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

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.