Telmisartan and Amlodipine Tablets 80 mg/5 mg — Class III drug recall D-1122-2019
Terminated recall by AVKARE Inc., reported 2019-04-17, distributed in AZ, CO. Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
| Recall number | D-1122-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2019-04-03 |
| Classified | 2019-04-11 |
| Reported by FDA | 2019-04-17 |
| Terminated | 2020-05-07 |
| Distributed | AZ, CO |
| Quantity | 397 bottles |
| Reason classes | specification failure |
| NDC | 42291-0795-30 |
| Lot numbers | 20092, 201916 |
| Expiration dates | 2019-08 |
Product
Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Reason for recall
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
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-1122-2019. 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.