Losartan Potassium Tablets — Class II drug recall D-1238-2020
Terminated recall by Golden State Medical Supply Inc., reported 2020-04-22, distributed nationwide. CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (AP
| Recall number | D-1238-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Golden State Medical Supply Inc., Camarillo, CA, United States |
| Recall initiated | 2020-04-03 |
| Classified | 2020-04-13 |
| Reported by FDA | 2020-04-22 |
| Terminated | 2020-10-08 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp, specification failure |
| NDC | 60429-0316-10, 60429-0316-30, 60429-0316-90 |
| Lot numbers | GS018406, GS018521, GS018605, GS018858, GS018911, GS019108 |
| Expiration dates | 2020-06-30, 2020-07-31 |
Product
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA
Reason for recall
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active 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-1238-2020. 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.