Browse Drug Recalls

94 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 94 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 94 FDA drug recalls.

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DateProductReasonClassFirm
May 9, 2022 T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Package... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Lidocaine 2% (20 mg/mL), Multi-Dose 30 mL vial , Rx Only, Olympia Pharmaceuti... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Sodium Bicarbonate 8.4% MDV Injection, Multi-Dose 30 mL vial, Rx Only, Olymp... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, R... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dos... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, ... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose ... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution,... Failed Reconstitution time Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Mu... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmac... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Pa... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . A... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile ... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Pa... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 ... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, ... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atro... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmace... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . A... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Mul... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 1... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Mult... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atro... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropi... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution,... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharma... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmace... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, ... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Apr 4, 2022 NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml... CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action L... Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution... Product found to be Sub Potent or Exceeded reconstitution time Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atro... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) ... Super Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 17... Super Potent and Failed Reconstitution Time Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% S... Sub Potent Class III Olympia Compounding Pharmacy dba Olympia Pharmacy
Mar 8, 2022 Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per... Sub Potent Class II Olympia Compounding Pharmacy dba Olympia Pharmacy

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.