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Browse Drug Recalls

4 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 4 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 4 FDA drug recalls.

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DateProductReasonClassFirm
Aug 28, 2017 Propafenone Hydrochloride tablets, 150 mg, packaged in 10 x 10 unit dose card... Failed moisture limits: Out of specification for moisture content. Class III Mckesson Packaging Services
Feb 7, 2014 Gelnique (oxybutynin chloride) Gel 10%, 100 mg in 1 g sachet, for topical use... Subpotent Drug: Drug potency was compromised during shipment. Class III Actavis
Dec 18, 2012 Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 36... Failed Dissolution Specification: Out of a specification result occurred during the 3-month stabi... Class II Watson Pharmaceuticals
Oct 19, 2012 Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg,... Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, be... Class II Watson Laboratories Inc

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.