Browse Drug Recalls

16 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 16 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 16 FDA drug recalls.

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DateProductReasonClassFirm
Dec 12, 2025 Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension, 300 mg,... Presence of particulate matter: potential presence of metal particulates in the product. Class II Merck Sharp & Dohme LLC
Dec 12, 2025 Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Onl... Presence of particulate matter: potential presence of metal particulates in the product. Class II Merck Sharp & Dohme LLC
Jul 21, 2025 Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton... Failed Dissolution Specifications: potential for delayed dissolution of the dose after administra... Class II Merck & Co. Inc
Mar 31, 2022 Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottl... Presence of foreign substance: Presence of stainless steel particulates in tablets. Class II MERCK SHARP & DOHME CORP
Oct 19, 2021 Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx onl... Presence of Particulate Matter: Identified as Glass Particles Class I MERCK SHARP & DOHME CORP
Mar 15, 2021 Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. T... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 M... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. T... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Dec 21, 2020 Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose... Lack of assurance of sterility: The results of sterility tests of seven batches of product were o... Class II Merck Sharp & Dohme
Aug 14, 2015 Vytorin (ezetimibe and simvastatin) tablets, 10 mg/20 mg, each tablet contain... Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin ... Class II Merck Sharp & Dohme, Wilson Facility
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
May 22, 2015 Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule,... Failed Stability Specification: out of specification result obtained for the Particle Size Distri... Class III Novartis Pharmaceuticals Corp.
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister... Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which c... Class III Merck & Co Inc
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister... This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... Class III Merck & Co Inc
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister... This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... Class III Merck & Co Inc
Jan 13, 2014 Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister... This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate... Class III Merck & Co 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.