Macleods Pharma recalls 100mg Losartan Potassium Tablets due to AZIDO impurity levels above safety limits. Affected lots include BLI2107B (exp 06/2023) and others. Stop using and contact for return.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Macleods Pharma is recalling 100mg Losartan Potassium Tablets that contain AZIDO impurities above safe levels. This could pose a health risk if taken as prescribed. Affected products include specific bottle counts and lot numbers.
The recall is for AZIDO impurities found in the medication that exceed acceptable safety limits. This could potentially cause health issues if the medication is taken as directed. The impurities are not harmful in normal use but may pose risks with long-term exposure.
People who have the recalled Losartan Potassium Tablets (100mg) from Macleods Pharma. Those with prescription medication for hypertension or kidney issues are most at risk.
Check for 100mg Losartan Potassium Tablets with NDC numbers 33342-046-07 (30-count), 33342-046-10 (90-count), or 33342-046-44 (1000-count). Look for lot numbers BLI2107B (exp 06/2023), BLI2101A (exp 12/2022), BLI2103A (exp 12/2022), or BLI2105A (exp 05/2023).
Immediately stop using the recalled Losartan Potassium Tablets if you have them.
The recall record states AZIDO impurities were observed above acceptable limits, but does not specify the exact impurity or its health effects.
Check the NDC numbers and lot numbers listed in the recall: 33342-046-07 (30-count), 33342-046-10 (90-count), 33342-046-44 (1000-count), and lot numbers BLI2107B, BLI2101A, BLI2103A, or BLI2105A.
The recall record does not specify a return process or instructions for disposal.
We’ve drafted a message you can send Macleods Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-0834-2022 — Macleods Pharma Macleods Pharma Hello, I own a Macleods Pharma that is covered by recall D-0834-2022 from Macleods Pharma. 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.