Class II · ModerateRecall completed
Losartan Potassium Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberMajor Label Unit Does 10 x 10 Cartons, Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.
Where it was soldNationwide.
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
Made byMajor Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152
| Distributed by / for | MAJOR PHARMACEUTICALS |
| NDC | 0904-6390-61 |
Show the full FDA record
| Full product label | Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152. |
| Recalling firm | MAJOR PHARMACEUTICALS |
| Distribution | Nationwide. |
| Quantity | 3,102 Cartons (310,200 tablets) |
| Recall initiated | 2019-01-10 |
| Report date | 2019-07-17 |
| Recall completed | 2023-02-19 |
| Recall number | D-1466-2019 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Livonia MI 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.