Class II · ModerateActive recall
Valsartan Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # 3081499, exp. date 3/2020 Lot # 3080009, exp. date 2/2020 Lot # 3080010, exp. date 2/2020 Lot # 3079205, exp. date 1/2020
Where it was soldProduct was distributed throughout the 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: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
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
Made byMade in India foreign manufacturer
| Distributed by / for | Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A |
| NDC | 0378-5815-77 |
Show the full FDA record
| Full product label | Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A., NDC 0378-5815-77. |
| Recalling firm | Mylan Pharmaceuticals Inc. |
| Distribution | Product was distributed throughout the United States. |
| Quantity | 25,147 bottles |
| Recall initiated | 2018-11-20 |
| Report date | 2018-12-19 |
| Recall completed | — |
| Recall number | D-0316-2019 |
| Classification | Class II |
| FDA status | Ongoing |
| 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.