Lupin Pharmaceuticals recalls 100mg Losartan Potassium Tablets with AZIDO impurities above safe levels. Stop using affected bottles to avoid potential health risks.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lupin Pharmaceuticals is recalling 100mg Losartan Potassium Tablets due to unsafe levels of an AZIDO impurity. This could pose health risks if taken, so affected users should stop using the product immediately.
The product contains an AZIDO impurity at levels above what is safe. This impurity could cause health problems if the medication is taken as directed, especially since it's a prescription drug.
People who have the specific 90-count or 1000-count bottles of Losartan Potassium Tablets (NDC# 68180-378-03 or 68180-378-09) prescribed by a doctor. Those with these products are at risk of potential health effects from the impurity.
Check for 90-count or 1000-count bottles labeled 'Losartan Potassium Tablets USP 100 mg' with NDC numbers 68180-378-03 or 68180-378-09. These were manufactured by Lupin Pharmaceuticals Inc. in Baltimore, Maryland.
Discontinue use of the recalled Losartan Potassium Tablets if you have the affected bottles.
The recall is due to AZIDO impurity levels observed to be above acceptable limits during manufacturing, which could pose health risks.
Stop using the product immediately and contact your doctor for alternative treatment options.
Yes, the affected bottles are 90-count (NDC# 68180-378-03) and 1000-count (NDC# 68180-378-09) bottles of Losartan Potassium Tablets 100 mg.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0840-2022 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0840-2022 from Lupin Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.