Class II · ModerateRecall completed
Amlodipine and Benazapril HCL Capsules
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot Numbers# 3083008 and 3086124, exp Jan 2019
Where it was soldProduct was distributed throughout United States
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
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
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 | Mylan Pharmaceuticals Inc. |
| NDC | 0378-6899-01 |
Show the full FDA record
| Full product label | Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01 |
| Recalling firm | Mylan Pharmaceuticals Inc. |
| Distribution | Product was distributed throughout United States |
| Quantity | 12,924 bottles |
| Recall initiated | 2018-04-24 |
| Report date | 2018-05-23 |
| Recall completed | 2019-06-20 |
| Recall number | D-0820-2018 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Morgantown WV 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.