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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 4,081–4,100 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 .

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0018-10.

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00

by Olympia Compounding Pharmacy dba Olympia Pharmacy

Reason
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Recall initiated
April 4, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA

by Teva Pharmaceuticals USA Inc

Reason
cGMP Deviations
Recall initiated
April 15, 2022
Reported by FDA
May 4, 2022
Distribution
Nationwide within the United States

View recall →

Drug Recall Completed Historical recordClass II

Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

by Glenmark Pharmaceuticals Inc., USA

Reason
cGMP deviations
Recall initiated
April 25, 2022
Reported by FDA
May 4, 2022
Distribution
USA nationwide

View recall →

Drug Recall Completed Historical recordClass II

Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01

by Glenmark Pharmaceuticals Inc., USA

Reason
cGMP deviations
Recall initiated
April 25, 2022
Reported by FDA
May 4, 2022
Distribution
USA nationwide

View recall →

Drug Recall Completed Historical recordClass II

Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01

by Glenmark Pharmaceuticals Inc., USA

Reason
cGMP deviations
Recall initiated
April 25, 2022
Reported by FDA
May 4, 2022
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59

by American Health Packaging

Reason
Subpotent Drug: Out of specification for assay.
Recall initiated
April 12, 2022
Reported by FDA
May 4, 2022
Distribution
Alabama

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.

by Preferred Pharmaceuticals, Inc.

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Recall initiated
April 12, 2022
Reported by FDA
May 4, 2022
Distribution
Nationwide within the U.S to CA, IN and FL.

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

by RemedyRePack Inc.

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Recall initiated
April 6, 2022
Reported by FDA
May 4, 2022
Distribution
Product was distributed to customers in AK and PA.

View recall →

Drug Recall Terminated Historical recordClass III

Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28.

by AptaPharma Inc.

Reason
Incorrect/Undeclared Excipient: Product contains alcohol
Recall initiated
March 29, 2022
Reported by FDA
May 4, 2022
Distribution
IL only

View recall →

Drug Recall Terminated Historical recordClass II

TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA Approved, 76590-8347-1, 3780 mL, 3.78 Liters (1 Gallon). Torco Race Fuels 2527 W. Dallas Ave. Apache Junction, AZ, 85120

by Torco Race Fuels

Reason
CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Recall initiated
April 21, 2022
Reported by FDA
May 4, 2022
Distribution
Distributed in the USA

View recall →

Drug Recall Ongoing Historical recordClass II

Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3

by Unilever United States Inc.

Reason
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Recall initiated
March 30, 2022
Reported by FDA
May 4, 2022
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass I

Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 75150 8), and b) 6 oz. cans (UPC 0 79400 78490 2), Dist. By Unilever, Trumbull, CT 06611

by Unilever United States Inc.

Reason
Chemical contamination: presence of benzene
Recall initiated
March 30, 2022
Reported by FDA
May 4, 2022
Distribution
Nationwide in the US

View recall →

Drug Recall Terminated Historical recordClass II

artnaturals Hand Sanitizer

by VIRGIN SCENT INC

Reason
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Recall initiated
October 26, 2021
Reported by FDA
April 27, 2022
Distribution
Nationwide in the U.S.A

View recall →

Drug Recall Terminated Historical recordClass I

artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5

by VIRGIN SCENT INC

Reason
Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
Recall initiated
October 26, 2021
Reported by FDA
April 27, 2022
Distribution
Nationwide in the U.S.A

View recall →

Drug Recall Terminated Historical recordClass II

LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA

by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Reason
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Recall initiated
April 5, 2022
Reported by FDA
April 27, 2022
Distribution
Nationwide within United States

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.