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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 6,441–6,460 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass III

Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61

by The Harvard Drug Group

Reason
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Recall initiated
December 13, 2019
Reported by FDA
February 26, 2020
Distribution
U.S.A. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton. Distributed by: GSK Consumer Healthcare, Warren, NJ 07059. NDC carton: 0067-6089-01, NDC packet: 0067-6089-03

by GSK Consumer Health, Inc

Reason
Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
Recall initiated
December 23, 2019
Reported by FDA
February 19, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 NDC 70518-1239-00

by RemedyRePack Inc.

Reason
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
Recall initiated
December 27, 2019
Reported by FDA
February 19, 2020
Distribution
Product distributed in OK and LA.

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Drug Recall Terminated Historical recordClass II

Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA

by Contract Pharmacal Corporation

Reason
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Recall initiated
February 3, 2020
Reported by FDA
February 19, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8

by Contract Pharmacal Corporation

Reason
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Recall initiated
February 3, 2020
Reported by FDA
February 19, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06

by Lupin Pharmaceuticals Inc.

Reason
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Recall initiated
February 12, 2020
Reported by FDA
February 19, 2020
Distribution
Nationwide within the United States.

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Drug Recall Terminated Historical recordClass II

Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister cards), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-266-21; NDC Unit Dose: 60687-266-11

by American Health Packaging

Reason
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Recall initiated
December 4, 2019
Reported by FDA
February 19, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-20

by AuroMedics Pharma LLC

Reason
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Recall initiated
February 7, 2020
Reported by FDA
February 19, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 00309 5

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
January 31, 2020
Reported by FDA
February 19, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166. UPC 0 00856 30106 1

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
January 31, 2020
Reported by FDA
February 19, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8

by Efficient Laboratories, Inc.

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
January 31, 2020
Reported by FDA
February 19, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablets per carton, Rx Only, Manufactured by: Almac Pharma Services Limited, Craigavon, BT63 5UA, UK; Manufactured for: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 0603-3718-34.

by Par Pharmaceutical Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Recall initiated
February 10, 2020
Reported by FDA
February 19, 2020
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/10 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2160-30.

by Pfizer Inc.

Reason
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Recall initiated
February 5, 2020
Reported by FDA
February 19, 2020
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Caduet (amlodipine besylate/atorvastatin calcium) Tablets, 10 mg/20 mg*, 30-count bottle, Rx only, Distributed by: Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Germany, NDC 0069-2180-30.

by Pfizer Inc.

Reason
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.
Recall initiated
February 5, 2020
Reported by FDA
February 19, 2020
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Kushim Tablets (Gushim) 45-count packages, Label in foreign language

by B AND A TRADING CORPORATION

Reason
Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin, and bufotenine
Recall initiated
January 28, 2020
Reported by FDA
February 19, 2020
Distribution
NY & NJ only

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Drug Recall Terminated Historical recordClass II

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.

by Akorn Inc

Reason
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Recall initiated
December 16, 2019
Reported by FDA
February 19, 2020
Distribution
Nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01

by Teva Pharmaceuticals USA

Reason
CGMP deviations: Product bottle may be absent of desiccant.
Recall initiated
January 27, 2020
Reported by FDA
February 19, 2020
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01

by Teva Pharmaceuticals USA

Reason
CGMP deviations: Product bottle may be absent of desiccant.
Recall initiated
January 27, 2020
Reported by FDA
February 19, 2020
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial, Each Tray contains 25 Vials, Intravenous or Intramuscular Use, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045, NDC 00409-9094-12 (vial), 00409-9094-22 (tray).

by Pfizer Inc.

Reason
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Recall initiated
February 3, 2020
Reported by FDA
February 19, 2020
Distribution
Nationwide in the U.S. and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-246-01.

by Zydus Pharmaceuticals USA Inc

Reason
cGMP Deviations
Recall initiated
January 31, 2020
Reported by FDA
February 19, 2020
Distribution
Nationwide in the U.S.

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.