LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count… — Class II drug recall D-1455-2019
Ongoing recall by Teva Pharmaceuticals USA, reported 2019-07-17, distributed nationwide. CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceuti
| Recall number | D-1455-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2019-06-06 |
| Classified | 2019-07-09 |
| Reported by FDA | 2019-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 2,924,000 tablets |
| Reason classes | cgmp, specification failure |
| NDC | 00591-3746-00 |
| Lot numbers | 1000, 1169752A, 1169753A, GS017387, GS017479, GS017651 |
| Expiration dates | 2020-01 |
Product
LOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-00
Reason for recall
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.