Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP — Class II drug recall D-1083-2019
Terminated recall by H J Harkins Company Inc dba Pharma Pac, reported 2019-04-17, distributed in CA. CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pha
| Recall number | D-1083-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | H J Harkins Company Inc dba Pharma Pac, Grover Beach, CA, United States |
| Recall initiated | 2019-03-04 |
| Classified | 2019-04-07 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2023-05-24 |
| Distributed | CA |
| Quantity | 300 tablets |
| Reason classes | cgmp, specification failure |
| NDC | 31722-0702-30, 76519-1033-03 |
| Lot numbers | 11/19, LOP17087, LTO00EW |
| Expiration dates | 2019-11 |
Product
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
Reason for recall
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
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-1083-2019. 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.