Class II · ModerateActive recall
Valsartan
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot Numbers: 472180001A, 472180002A, 472180003A, 472180004A, exp. date Jan 2020; 472180007A, 472180008A, 472180009A, 472180010A, exp. date Mar 2020; 472180013A, 472180014A, exp. date Apr 2020
Where it was soldProduct was distributed to major distribution chains 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
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found 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 byAurobindo Pharma Limited
| Brand name | VALSARTAN |
| Generic name | VALSARTAN |
| Active ingredient(s) | VALSARTAN |
| Distributed by / for | Aurobindo Pharma USA, Inc., Dayton, NJ --- |
| NDC | 65862-572-90 |
Show the full FDA record
| Full product label | Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90 |
| Recalling firm | Aurobindo Pharma USA Inc. |
| Distribution | Product was distributed to major distribution chains throughout the United States. |
| Quantity | N/A |
| Recall initiated | 2018-12-31 |
| Report date | 2019-03-27 |
| Recall completed | — |
| Recall number | D-1039-2019 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | East Windsor NJ 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.