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Browse Drug Recalls

12 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 12 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 12 FDA drug recalls.

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DateProductReasonClassFirm
Aug 6, 2020 Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesvill... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Fa... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy o... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmac... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of S... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharm... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmac... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 m... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy ... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville

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.