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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
Apr 16, 2014 Pristiq (desvenlafaxine) Extended-Release Tablets 50 mg, 30 count bottle, Rx ... Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended... Class II Pfizer Us Pharmaceutical Group
Mar 6, 2014 Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a... Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg ca... Class I Pfizer Us Pharmaceutical Group
Feb 26, 2014 Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 cou... Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphe... Class III Pfizer Us Pharmaceutical Group
Sep 4, 2013 Aldactone (spironolactone) tablets, USP, 100 mg, 100-count bottles, Rx only, ... Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the d... Class II Pfizer Us Pharmaceutical Group

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.