FlaggedRx← Medication recall checkHome
Class II · ModerateRecall completed

Losartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90

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

Does this affect you?
Check your lot numberGS014045,exp 06/2019, GS014305 exp 06/2019, GS014044 exp 0/2019, GS016535 exp 01/2020, GS016524 exp 01/2020, GS017384 exp 02/2020, GS017385 exp 01/2020, GS017539 exp 01/2020, GS017540 exp 01/2020, GS017543 exp 01/2020, GS017542 exp 01/2020 GS017984 exp 02/2020, GS017985 exp 02/2020, GS017986 exp 02/2020, GS018263 exp 02/2020, GS018264 exp 02/2020, GS018265 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

  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 / forGolden State Medical Supply Inc.
NDC60429-318-90
Show the full FDA record
Full product labelLosartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated
Recalling firmGolden State Medical Supply Inc.
DistributionIL, MI, MN, PA, TN, TX. Two (2) US government and one (1) Veterans Affairs accounts. No foreign accounts.
Quantity138,213 HDPE Bottles
Recall initiated2019-05-01
Report date2019-05-29
Recall completed2020-02-25
Recall numberD-1285-2019
ClassificationClass II
FDA statusTerminated
Origin on fileCamarillo CA United States

Related

Losartan recallsRecent drug recallsCheck another medication

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.