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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.