Class II · ModerateRecall completed
Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberGS015204 exp 06/ 2019, GS018318 exp 02/2020, GS014817 exp 06/2019, GS017342 exp 02/2020, GS017808 exp 02/2020
Where it was soldIL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
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 of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the 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 | Golden State Medical Supply Inc. |
| NDC | 60429-316-10 |
Show the full FDA record
| Full product label | Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated |
| Recalling firm | Golden State Medical Supply Inc. |
| Distribution | IL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts. |
| Quantity | 11,286 HDPE Bottles |
| Recall initiated | 2019-05-01 |
| Report date | 2019-05-29 |
| Recall completed | 2020-02-25 |
| Recall number | D-1284-2019 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Camarillo CA 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.