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Browse Drug Recalls

18 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18 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 18 FDA drug recalls.

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DateProductReasonClassFirm
Jun 26, 2019 Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, Firs... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx on... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associat... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Phar... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 m... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pha... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, F... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, ... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First P... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma As... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, ... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only,... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Assoc... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)1... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...
Jun 26, 2019 PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma ... Lack of Assurance of Sterility. Class II First Pharma Associates LLC dba Riverpoint Phar...

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.