LOSARTAN POTASSIUM TABLETS — Class II drug recall D-1100-2020
Ongoing recall by Teva Pharmaceuticals USA, reported 2020-04-15, distributed in CA. CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceuti
| Recall number | D-1100-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2020-03-25 |
| Classified | 2020-04-07 |
| Reported by FDA | 2020-04-15 |
| Distributed | CA |
| Reason classes | cgmp, specification failure |
| NDC | 00591-3745-00 |
| Lot numbers | 1207342A, 1207343A, 1207344A |
| Expiration dates | 2020-06, 2020-07 |
Product
LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1100-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.