RemedyRepack Recalls Losartan HCTZ Due to Azido Impurity
RemedyRepack Inc. recalls specific lots of Losartan HCTZ 50/12.5 mg bottles due to CGMP deviations and azido impurity levels above acceptable limits.
Use caution until it’s fixed
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Contact the company
What happened, in plain English
RemedyRepack Inc. is recalling Losartan HCTZ 50/12.5 mg, 90-count bottles because manufacturing quality control failures resulted in azido impurity levels exceeding acceptable limits. The affected products were distributed to Florida and include lots B1377711-100521 and B1412137-102621, both expiring on 10/31/2022. The record does not specify the remedy or actions consumers should take. Read more at govinfonow.com/recall/34795-remedyrepack-recalls-losartan-hctz-due-to-azido-impurity.
Source Summary by GovInfoNow · govinfonow.com/recall/34795-remedyrepack-recalls-losartan-hctz-due-to-azido-impurity · Updated October 10, 2026 · FDA enforcement record: FDA #D-0885-2022
Cite this page
“RemedyRepack Recalls Losartan HCTZ Due to Azido Impurity.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34795-remedyrepack-recalls-losartan-hctz-due-to-azido-impurity. Based on FDA recall #D-0885-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0885-2022%22&limit=1).
Why it’s dangerous
The recall is due to Current Good Manufacturing Practice (CGMP) deviations that caused azido impurity levels to be observed above acceptable limits. The specific health risks or injury mechanisms associated with this impurity are not described in the provided record.
Who’s affected
Individuals in Florida who purchased Losartan HCTZ 50/12.5 mg, 90-count bottles from RemedyRepack Inc. with lot numbers B1377711-100521 or B1412137-102621 and expiration dates of 10/31/2022.
How to tell if you have this one
Check your medication bottle for the brand RemedyRepack Inc., product name Losartan HCTZ 50/12.5 mg, and a 90-count size. Verify the Original NDC# 33342-0050-10 or Repackaged NDC# 70518-3231-00, and confirm the lot number is either B1377711-100521 or B1412137-102621 with an expiration date of 10/31/2022.
- Brand
RemedyRepack Inc.- Category
Drug
Where it went and when
Where it was distributed
Distributed in Florida.
FDA distribution: “Recalled product was distributed to Florida.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #D-0885-2022 (May 4, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0885-2022 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.