Valsartan Tablets 320 mg USP — Class II drug recall D-1055-2019
Ongoing recall by Rising Pharmaceuticals, Inc., reported 2019-03-27, distributed nationwide. CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in fin
| Recall number | D-1055-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rising Pharmaceuticals, Inc., Saddle Brook, NJ, United States |
| Recall initiated | 2019-03-07 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Distributed | Nationwide (US) |
| Quantity | 42,016 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 52343-0125-90 |
| Expiration dates | 2019-10-31, 2020-03-31, 2020-04-30, 2020-07-31 |
Product
Valsartan Tablets 320 mg USP, 90 tablet bottles, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-125-90
Reason for recall
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
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-1055-2019. 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.