Class II · ModerateRecall completed
Losartan Potassium 50 mg Tablet
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # B1467803-120621, exp. date 06/30/2022 Lot # J0585793-121721, exp. date 12/31/2022
Where it was soldProduct was distributed to customers in AK and PA.
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- AZIDO Impurity levels observed to be above acceptable limits.
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 | RemedyRepack Inc. |
| NDC | 70518-3282-1 |
Show the full FDA record
| Full product label | Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202. |
| Recalling firm | RemedyRepack Inc. |
| Distribution | Product was distributed to customers in AK and PA. |
| Quantity | 433/30 count blister cards, 33/60 count blister cards |
| Recall initiated | 2022-04-06 |
| Report date | 2022-05-04 |
| Recall completed | 2022-05-27 |
| Recall number | D-0788-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Indiana PA 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.