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Class II · ModerateRecall completed

Losartan Potassium Tab. USP 50mg

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numbera) 30 tablets: lot A1818G batch 01181807 exp 3/2020; b) 90 tablets: lot L0517L batch 12051712 exp 3/2020
Where it was soldCA, GA, IN. No DOD/VA 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

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Distributed by / forPreferred Pharmaceuticals, Inc
NDC68788-0048-03
Show the full FDA record
Full product labelLosartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
Recalling firmPreferred Pharmaceuticals, Inc
DistributionCA, GA, IN. No DOD/VA accounts. No foreign accounts.
Recall initiated2019-04-30
Report date2019-05-22
Recall completed2023-04-03
Recall numberD-1281-2019
ClassificationClass II
FDA statusTerminated
Origin on fileAnaheim CA United States

Related

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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.