Valsartan Tablets USP 160 mg — Class II drug recall D-1047-2019
Terminated recall by American Health Packaging, reported 2019-03-27, distributed nationwide. CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingre
| Recall number | D-1047-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Health Packaging, Columbus, OH, United States |
| Recall initiated | 2019-03-06 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2020-09-09 |
| Distributed | Nationwide (US) |
| Quantity | 3,337 cartons |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 60687-0139-01, 60687-0139-11 |
| Lot numbers | 179791 |
Product
Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
Reason for recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active 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-1047-2019. 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.