Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-05-11FDA-DrugLupin Pharmaceuticals Inc.Class IILosartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-11FDA-DrugLupin Pharmaceuticals Inc.Class IILosartan 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.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-11FDA-DrugLupin Pharmaceuticals Inc.Class IILosartan 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.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-11FDA-DrugMacleods Pharma Usa IncClass IILosartan 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
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-11FDA-DrugMacleods Pharma Usa IncClass IILosartan 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
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-11FDA-DrugMacleods Pharma Usa IncClass IILosartan 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
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-11FDA-DrugMacleods Pharma Usa IncClass IILosartan 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
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-11FDA-DrugMacleods Pharma Usa IncClass IILosartan 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
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-11FDA-DrugMacleods Pharma Usa IncClass IILosartan 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
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- 2022-05-11FDA-DrugSCA PharmaceuticalsClass IIVancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44
CGMP Deviations
- 2022-05-11FDA-DrugSCA PharmaceuticalsClass IIFentanyl 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
CGMP Deviations
- 2022-05-11FDA-DrugSCA PharmaceuticalsClass IINorepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40
CGMP Deviations
- 2022-05-04FDA-DrugMylan Pharmaceuticals IncClass IInsulin 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
Labeling: Missing label on the vial
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IINAD+ 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
Failed Reconstitution time
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISincalide. 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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIHydroxocobalamin 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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIUltratest, 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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IITestosterone 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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IITestosterone 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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIPhenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIFormula 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.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIT-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIPGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0030-10.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIPGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0029-10.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIPGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIFA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0006-10.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIBIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIRE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIRE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
- 2022-05-04FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIQM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0020-10.
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Get notified about new drug recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief