RemedyRePack recalls Losartan HCTZ 100/25 mg tablets due to AZIDO impurity levels above safety limits. Affected lots expired by 10/31/2022.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
RemedyRePack is recalling Losartan HCTZ 100/25 mg tablets that were repackaged from the original NDC 68180-0217-09. The recall is due to AZIDO impurity levels exceeding acceptable safety limits, which could pose a health risk.
AZIDO impurities in the medication can potentially cause health risks when taken. The impurity levels were found to be above the acceptable limits set by regulatory standards, which could lead to adverse effects if the medication is used as intended.
People who purchased Losartan HCTZ 100/25 mg tablets with the repackaged NDC 70518-2578-00 from the listed lots. Those with hypertension or kidney conditions may be at higher risk.
Check for the repackaged NDC 70518-2578-00 on the bottle. The affected lots include B1329507-082921 (exp. 08/31/2022), B1348363-091421 (exp. 09/30/2022), B1387286-101021 (exp. 10/31/2022), B1390974-101221 (exp. 10/31/2022), and B1426010-110521 (exp. 11/30/2022).
Look for the repackaged NDC 70518-2578-00 on the bottle label and check the lot numbers listed in the recall notice.
The recall notice states that AZIDO impurity levels were above acceptable limits, so the medication is not safe to take as recalled. Consult your doctor for advice.
The recall does not specify a remedy, so contact RemedyRePack directly for guidance on what to do with the affected product.
Check the bottle for the repackaged NDC 70518-2578-00 and the specific lot numbers listed in the recall notice: B1329507-082921, B1348363-091421, B1387286-101021, B1390974-101221, or B1426010-110521.
We’ve drafted a message you can send RemedyRePack to request your refund or repair — edit it as you like.
Subject: Recall D-0886-2022 — RemedyRePack RemedyRePack Hello, I own a RemedyRePack that is covered by recall D-0886-2022 from RemedyRePack. 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.