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Unrated Drug recall · FDA · Published April 6, 2022

RemedyRePack Losartan 50mg Tablets Recall: AZIDO Impurity Risk

RemedyRePack recalls Losartan Potassium 50mg tablets with AZIDO impurities above safety limits. Stop using if you have these specific blister packs.

🇺🇸 FDA recall #D-0788-2022DrugRemedyRePack ›
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Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571
✎ GovInfoNow plain-language explainer

RemedyRePack is recalling Losartan Potassium 50mg tablets due to unsafe levels of an impurity called AZIDO. This could pose health risks if taken as directed. Read more at govinfonow.com/recall/34972-remedyrepack-losartan-50mg-tablets-recall-azido-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/34972-remedyrepack-losartan-50mg-tablets-recall-azido-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0788-2022

Cite this page

“RemedyRePack Losartan 50mg Tablets Recall: AZIDO Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34972-remedyrepack-losartan-50mg-tablets-recall-azido-impurity-risk. Based on FDA recall #D-0788-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0788-2022%22&limit=1).

The FDA announced on April 6, 2022, that RemedyRePack Inc. is recalling Losartan Potassium 50 mg tablets due to azido impurity levels exceeding acceptable limits. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: RemedyRePack
  • Product: Losartan Potassium 50 mg Tablet
  • NDC# 70518-3282-1 (30-count blister card)
  • NDC# 70518-3282-0 (60-count blister card)
  • Lot # B1467803-120621, exp. date 06/30/2022
  • Lot # J0585793-121721, exp. date 12/31/2022

The hazard

The recall addresses CGMP deviations where azido impurity levels were observed to be above acceptable limits.

Context

GovInfoNow's records show RemedyRePack Inc. has 35 other recalls on record since February 18, 2015. Recent brand recalls include Clindamycin Capsules recalled on April 22, 2025, and March 24, 2025, due to CGMP deviations, as well as Carvedilol Tablets recalled on January 24, 2025, for N-Nitroso impurity risk. Other recent recalls of similar products include Amneal traMADol 50mg Tablets (March 19, 2026), Zydus Mirabegron 25mg Tablets (August 5, 2026), and Macleods Olanzapine Tablets 5mg (August 27, 2026).

How to tell if you have this one

Check for 30-count or 60-count blister packs labeled with NDC numbers 70518-3282-1 or 70518-3282-0. The lot numbers and expiration dates listed in the recall are also key identifiers.

  • Brand
    RemedyRePack
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Look for the specific blister packs with NDC numbers 70518-3282-1 or 70518-3282-0.

Where it went and when

Where it was distributed

Distributed in Alaska and Pennsylvania.

Alaska: yesAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “Product was distributed to customers in AK and PA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alaska, Pennsylvania.

Recall timeline

FDA terminated this recall 51 days after the firm started it.

1. Firm started the recall: Apr 6, 202212. FDA classified it Class II: Apr 26, 202223. Published in FDA’s Enforcement Report: May 4, 202234. FDA terminated the recall: May 27, 202242022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-0788-2022 (April 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0788-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA