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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Sep 30, 2022 Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured ... Out of specification for related substances (impurities). Class II Ingenus Pharmaceuticals Llc
Jan 10, 2022 Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50)... CGMP Deviations Class II Ingenus Pharmaceuticals Llc
Oct 9, 2019 Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose ... Crystallization: Presence of particulate matter identified as API crystallization Class II Ingenus Pharmaceuticals Llc
Mar 18, 2019 Diclofenac Sodium Topical Solution, 1.5% w/w, 5 FL. OZ. (150 mL) bottle, Rx O... Defective Container: firm discovered samples stored horizontally as well as product quality compl... Class III Ingenus Pharmaceuticals Llc
Jun 8, 2018 Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Sing... Superpotent Drug: High out of specification assay value results for potency. Class II Ingenus Pharmaceuticals Llc
Jun 8, 2018 Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Sin... Superpotent Drug: High out of specification assay value results for potency. Class II Ingenus Pharmaceuticals Llc

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.