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Browse Drug Recalls

5 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 5 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 5 FDA drug recalls.

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DateProductReasonClassFirm
May 8, 2017 HYDROCORTISONE LOTION, USP, 2.5%, 2 FL OZ (59 mL) bottle, Rx only, Manufactur... Superpotent Drug: above specification for the assay. Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Dec 22, 2016 TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for:... Failed Stability Specifications Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Oct 21, 2015 RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 m... Failed Stability Specifications: Out of Specification results obtained for preservative butylpara... Class III Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Oct 7, 2015 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 3000 count bottles, Rx only, Manu... Presence of Particulate Matter. Class II Vintage Pharmaceuticals LLC, DBA Qualitest Phar...
Aug 13, 2015 AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured fo... Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling. Class III Vintage Pharmaceuticals LLC, DBA Qualitest 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.