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Boehringer Ingelheim Pharmaceuticals, Inc. FDA Recalls
3 recalls on file across drugs, 0 of them Class I and 1 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Synjardy XR Tablets (empagliflozin and metformin hydrochloride extended-release tablets), 12.5/1000 mg, 60 Tablets per BClass IIJun 12, 2026CGMP Deviations: An incorrect detergent was used and the req |
| JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bClass IIMar 9, 2023Labeling: Label Mix-up |
| Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx only, NDC 0597-0041-37), Distributed by: BClass IIMay 4, 2021Subpotent Drug |