Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 4,041–4,060 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
March 31, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
March 31, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

by Macleods Pharma Usa Inc

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
April 15, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

by Macleods Pharma Usa Inc

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
April 15, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

by Macleods Pharma Usa Inc

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
April 15, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

by Macleods Pharma Usa Inc

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
April 15, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

by Macleods Pharma Usa Inc

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
April 15, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536

by Macleods Pharma Usa Inc

Reason
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recall initiated
April 15, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44

by SCA Pharmaceuticals

Reason
CGMP Deviations
Recall initiated
April 25, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32

by SCA Pharmaceuticals

Reason
CGMP Deviations
Recall initiated
April 25, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40

by SCA Pharmaceuticals

Reason
CGMP Deviations
Recall initiated
April 25, 2022
Reported by FDA
May 11, 2022
Distribution
Product was distributed nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass I

Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80

by MYLAN PHARMACEUTICALS INC

Reason
Labeling: Missing label on the vial
Recall initiated
April 12, 2022
Reported by FDA
May 4, 2022
Distribution
USA nationwide.

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
Failed Reconstitution time
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

Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00.

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

Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0080-30.

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

Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10.

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

Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0055-10; b) 5 mL Multi-Dose vial, NDC 73198-0055-05, 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

Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0054-10; b) 5 mL Multi-Dose vial, NDC 73198-0054-05, 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

Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05.

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

Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.

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 →

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.