Camber Pharmaceuticals — Class II drug recall D-1116-2018
Completed recall by Hetero Labs Limited Unit V, reported 2018-08-29, distributed nationwide. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1116-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar, India |
| Recall initiated | 2018-08-08 |
| Classified | 2018-08-23 |
| Reported by FDA | 2018-08-29 |
| Distributed | Nationwide (US) |
| Quantity | 441,408 bottles |
| Reason classes | cgmp, specification failure |
| UPC / GTIN / UDI-DI | 00331722748902 |
| NDC | 31722-0745, 31722-0745-05, 31722-0745-30, 31722-0745-31, 31722-0745-32, 31722-0745-90, 31722-0746, 31722-0746-05, 31722-0746-30, 31722-0746-31, 31722-0746-32, 31722-0746-90, 31722-0747, 31722-0747-05, 31722-0747-30, 31722-0747-31, 31722-0747-32, 31722-0747-90, 31722-0748, 31722-0748-05, 31722-0748-30, 31722-0748-31, 31722-0748-32, 31722-0748-90 |
| Expiration dates | 2018-07 |
Product
Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902
Reason for recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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-1116-2018. 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.