Browse Drug Recalls

20 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 20 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 20 FDA drug recalls.

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DateProductReasonClassFirm
Jun 17, 2024 Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count... Failed dissolution specifications: this product is being recalled due to this batch not meeting d... Class II Trigen Laboratories
Mar 15, 2021 Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplemen... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Feb 28, 2018 Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count... Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to ... Class III Osmotica Pharmaceutical Corp
Dec 18, 2017 Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count ... Subpotent Drug Class III Osmotica Pharmaceutical Corp
Dec 18, 2017 Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count ... Subpotent Drug Class III Osmotica Pharmaceutical Corp
Apr 17, 2014 Triveen - PRx RNF Capsules, 30-count bottles, Rx only; Manufactured for: Trig... Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 mic... Class III Trigen Laboratories, Inc.
Jan 30, 2013 TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz. bottle,... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Tri-Dex PE, Antihistamine, Antitussive, Nasal Decongestant, 16 fl oz. bottle,... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Mesehist WC, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OT... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz.... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Man... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufacture... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, M... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Ma... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactur... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bot... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz.... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, Inc.
Jan 30, 2013 CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. ... CGMP Deviations: Products are underdosed or have an incorrect dosage regime. Class II TG United, 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.