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Browse Drug Recalls

55 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 55 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 55 FDA drug recalls.

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DateProductReasonClassFirm
Apr 6, 2020 Bi-Est 1:1/Progest/DHEA 0.5 mg/180 mg/25 mg/mL Cream 30 mL jar, Rx, The Medic... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Paregoric Compound (contains Morphine) Solution 480 mL bottle, Rx, The Medici... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Fluorouracil (5-FU) 4.5% Cream 100 GM, tube Rx, The Medicine Shoppe Pharmacy,... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Bi-Est (1:1)/Progesterone/Testosterone 2.5/150/1.5 mg/mL Versabase CR 90 mL b... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Mar 16, 2020 Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tam... Lack of Assurance of Sterility Class II The Medicine Shoppe 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.