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Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Apr 20, 2017 Phenobarbital Tablets USP, 100 mg, a) 100 count bottles (NDC 0463-6152-01), b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 60 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactur... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class II C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 15 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Labeled Error on Declared Strength; report of a 1000 ct bottle labeled as Phenobarbital... Class I C. O. Truxton
Apr 20, 2017 Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured b... Labeling: Label Mixup; potentially mislabeled Class I C. O. Truxton
Aug 24, 2015 Doxycycline Hyclate Tablets, USP, 100 mg, 500-count bottle, Rx only, Distribu... Labeling: Wrong Bar Code Class II C. O. Truxton

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.