Class III · Lower riskRecall completed
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLots: 201916 Exp. 08/2019; 20092 Exp. 08/2019
Where it was soldAZ, CO
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | AvKARE, Inc. Pulaski, TN 38478 --- |
| NDC | 42291-795-30 |
Show the full FDA record
| Full product label | Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30 |
| Recalling firm | AVKARE Inc. |
| Distribution | AZ, CO |
| Quantity | 397 bottles |
| Recall initiated | 2019-04-03 |
| Report date | 2019-04-17 |
| Recall completed | 2020-05-07 |
| Recall number | D-1122-2019 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Pulaski TN United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.