Losartan Potassium Tablets — Class II drug recall D-1287-2019
Terminated recall by Heritage Pharmaceuticals, Inc., reported 2019-05-29, distributed nationwide. CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished
| Recall number | D-1287-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Heritage Pharmaceuticals, Inc., East Brunswick, NJ, United States |
| Recall initiated | 2019-05-03 |
| Classified | 2019-05-21 |
| Reported by FDA | 2019-05-29 |
| Terminated | 2020-11-16 |
| Distributed | Nationwide (US) |
| Quantity | 3,012 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 23155-0645-10 |
| Lot numbers | CLO17007A, CLO17008A, CLO17009A |
| Expiration dates | 2019-11 |
Product
Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-10
Reason for recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
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-1287-2019. 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.