Browse Drug Recalls
13 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 13 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 13 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.