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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 6,361–6,380 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01

by Mayne Pharma Inc

Reason
Product Mix-Up: A foreign tablet was found in bottle.
Recall initiated
March 2, 2020
Reported by FDA
March 18, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, NDC 53050-0002-01

by Sunstar Guangzhou Ltd.

Reason
cGMP Deviation
Recall initiated
February 28, 2020
Reported by FDA
March 18, 2020
Distribution
Florida only

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Drug Recall Terminated Historical recordClass II

Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. NDC 0069-0106-01

by Pfizer Inc.

Reason
Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Recall initiated
February 27, 2020
Reported by FDA
March 11, 2020
Distribution
Nationwide within the United States and Albania, Israel, Serbia, Macedonia, Afghanistan, Botswana/South Africa/Zimbabwe, India, Israel, Rwanda, Uruguay, Mongolia

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Drug Recall Terminated Historical recordClass II

Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0224-3

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

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Drug Recall Terminated Historical recordClass II

Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0251-3

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

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Drug Recall Terminated Historical recordClass II

Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0210-3

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

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Drug Recall Terminated Historical recordClass II

Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

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Drug Recall Terminated Historical recordClass II

Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0625-1

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC # 71283-0633-1

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0635-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

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Drug Recall Terminated Historical recordClass II

Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE, For IM Use, 2 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0531-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE, For IM Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-1

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0234-3

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0227-3

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For IV, IM Use, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0216-3

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For IA Use, 5 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-1413-5

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

View recall →

Drug Recall Terminated Historical recordClass II

Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE, For IV, IM Use, Refrigerate, 10 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0336-1

by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

Reason
Lack of Assurance of Sterility
Recall initiated
January 15, 2020
Reported by FDA
March 11, 2020
Distribution
U.S.A. Nationwide and Puerto Rico, Barbados and Dominican Republic

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.