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Class II · ModerateRecall completed

Losartan Potassium and Hydrochlorothiazide Tablets

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

Does this affect you?
Check your lot numberLot BLM715A, Jul-19
Where it was soldNJ, NY, FL
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 Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

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

Made byMacleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India foreign manufacturer
Distributed by / forMacleods Pharma USA, Inc., Plainsboro, NJ 08536
NDC33342-0052-10
Show the full FDA record
Full product labelLosartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
Recalling firmMacleods Pharma Usa Inc
DistributionNJ, NY, FL
Quantity9695 bottles
Recall initiated2019-02-21
Report date2019-03-27
Recall completed2020-09-28
Recall numberD-1040-2019
ClassificationClass II
FDA statusTerminated
Origin on filePlainsboro NJ United States

Related

Losartan recallsHydrochlorothiazide 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.