Class II · ModerateRecall completed
Losartan Potassium
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberNDC [redacted-phone] Lot 7901007A, Exp Date Jun-22; Lot 7901144A, 7901178A & 7901179A, Exp Date Sep-22; Lots 7901246A & 7901247A, Exp Date Oct-22; Lot 7901343A, Exp Date Dec-22. NDC [redacted-phone] Lot 7901006A, Exp Date Jun-22; Lot 7901145A & 7901180A, Exp Date Sep-22; Lot 7901181A, Exp Date Oct-22.
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- 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
Made byVivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets foreign manufacturer
| Brand name | LOSARTAN POTASSIUM |
| Generic name | LOSARTAN POTASSIUM |
| Active ingredient(s) | LOSARTAN POTASSIUM |
| Distributed by / for | Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets |
| NDC | 64380-933-05 |
Show the full FDA record
| Full product label | Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-08 |
| Recalling firm | Strides Pharma Inc. |
| Distribution | Nationwide |
| Quantity | 200407 bottles |
| Recall initiated | 2022-05-18 |
| Report date | 2022-06-08 |
| Recall completed | 2023-10-20 |
| Recall number | D-0972-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | East Brunswick 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.