Losartan Potassium Tablets USP — Class II drug recall D-1043-2019
Ongoing recall by Camber Pharmaceuticals Inc, reported 2019-03-27, distributed nationwide. CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharma
| Recall number | D-1043-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Camber Pharmaceuticals Inc, Piscataway, NJ, United States |
| Recall initiated | 2019-02-28 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 683,641 bottles |
| Reason classes | cgmp |
| NDC | 31722-0700, 31722-0700-05, 31722-0700-10, 31722-0700-30, 31722-0700-60, 31722-0700-90, 31722-0701, 31722-0701-05, 31722-0701-10, 31722-0701-30, 31722-0701-60, 31722-0701-90, 31722-0702, 31722-0702-05, 31722-0702-10, 31722-0702-30, 31722-0702-60, 31722-0702-90 |
| Lot numbers | LOP17087, NOV-19 |
Product
Losartan Potassium Tablets USP, 100 mg, Rx only, a) 30 count (NDC 31722-702-30), b) 90 count (NDC 31722-702-30), c) 1000 count (NDC 31722-702-10) bottles, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar -509 301, India
Reason for recall
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
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-1043-2019. 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.