AvKARE Valsartan and Hydrochlorothiazide 320 mg/12 — Class II drug recall D-1176-2018
Terminated recall by Avkare Incorporated, reported 2018-09-12, distributed nationwide. CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
| Recall number | D-1176-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Avkare Incorporated, Pulaski, TN, United States |
| Recall initiated | 2018-07-18 |
| Classified | 2018-09-06 |
| Reported by FDA | 2018-09-12 |
| Terminated | 2020-05-07 |
| Distributed | Nationwide (US) |
| Quantity | 12,950 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 42291-0886-90 |
| Lot numbers | 17780, 18029, 18398, 18723, 19017, 19224, 20032, 20289, 21076, 21382 |
| Expiration dates | 2018-09, 2019-02, 2019-08 |
Product
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
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-1176-2018. 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.