Valsartan Tablets — Class II drug recall D-0209-2018
Terminated recall by Prinston Pharmaceutical Inc, reported 2018-01-17, distributed nationwide. Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
| Recall number | D-0209-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prinston Pharmaceutical Inc, Cranbury, NJ, United States |
| Recall initiated | 2017-11-29 |
| Classified | 2018-01-08 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2019-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 21,987 bottles |
| NDC | 43547-0367, 43547-0367-03, 43547-0367-09, 43547-0367-11, 43547-0367-50, 43547-0368, 43547-0368-03, 43547-0368-09, 43547-0368-11, 43547-0368-50, 43547-0369, 43547-0369-03, 43547-0369-09, 43547-0369-11, 43547-0369-50, 43547-0370, 43547-0370-03, 43547-0370-09, 43547-0370-11, 43547-0370-50 |
| Lot numbers | 343B17025 |
| Expiration dates | 2019-03-31 |
Product
Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09.
Reason for recall
Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.
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-0209-2018. 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.