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Unrated Drug recall · FDA · Published April 12, 2022

Preferred Pharmaceuticals recalls Losartan 50mg tablets due to unsafe impurity levels

Preferred Pharmaceuticals recalls 30-count Losartan Potassium 50mg tablets (Lupin Pharmaceuticals) with high azido impurity levels. Consumers should check lot numbers on packaging for affected batches.

🇺🇸 FDA recall #D-0789-2022DrugPreferred Pharmaceuticals ›
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Recalling firmPreferred Pharmaceuticals, Inc.1250 N Lakeview Ave Ste O · Anaheim, CA 92807-1801
✎ GovInfoNow plain-language explainer

Preferred Pharmaceuticals is recalling 30-count Losartan Potassium 50mg tablets made by Lupin Pharmaceuticals due to unsafe levels of an impurity called azido. This could pose a health risk if taken by people with certain conditions. Read more at govinfonow.com/recall/34969-preferred-pharmaceuticals-recalls-losartan-50mg-tablets-due-to-unsafe-impurity.

Source Summary by GovInfoNow · govinfonow.com/recall/34969-preferred-pharmaceuticals-recalls-losartan-50mg-tablets-due-to-unsafe-impurity · Updated August 18, 2026 · FDA enforcement record: FDA #D-0789-2022

Cite this page

“Preferred Pharmaceuticals recalls Losartan 50mg tablets due to unsafe impurity levels.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34969-preferred-pharmaceuticals-recalls-losartan-50mg-tablets-due-to-unsafe-impurity. Based on FDA recall #D-0789-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0789-2022%22&limit=1).

The FDA announced on April 12, 2022, that Preferred Pharmaceuticals, Inc. voluntarily recalled Losartan Potassium Tab. USP 50mg due to azido impurity levels exceeding acceptable limits. The recall involves specific lots distributed nationwide to California, Indiana, and Florida.

How to tell if you have it

  • Brand: Preferred Pharmaceuticals
  • Product: Losartan Potassium Tab. USP 50mg
  • Manufacturer: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
  • Lot codes: E1321O, E2521H, E2621F
  • Expiration date: 5/31/2023
  • Package sizes: 30 tablets, 90 tablets
  • Distribution: Nationwide within the U.S. to CA, IN and FL

The hazard

The recall was initiated because current good manufacturing practice (CGMP) deviations resulted in azido impurity levels observed to be above acceptable limits. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Preferred Pharmaceuticals, Inc. has 31 other recalls on record since August 15, 2018. Other recent recalls of similar products include Geri-Care Eye Drops Recalled for Sterility Risk (March 25, 2026) and Preferred Pharma Recalls Ondansetron ODT Due to Defective Seals (November 17, 2025). Additional related actions noted in records are Preferred Pharma Recalls Clindamycin Capsules Due to cGMP Deviations (April 18, 2025), Amneal traMADol 50mg Tablets Recall: NDSRI Impurity Risk (March 19, 2026), Lupin Ganirelix Acetate Injection Recall: Impurity Risk (November 13, 2025), and Ajanta Pharma Recalls Duloxetine Capsules Due to Nitrosamine Impurity Risk (April 29, 2026).

How to tell if you have this one

Check the packaging for lot numbers E1321O, E2521H, or E2621F that expire May 31, 2023. The product is sold in 30-count packages.

  • Brand
    Preferred Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Lot Number

    Look for lot numbers E1321O, E2521H, or E2621F on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: named in the noticeINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Nationwide within the U.S to CA, IN and FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Indiana.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

1. Firm started the recall: Apr 12, 202212. FDA classified it Class II: Apr 26, 202223. Published in FDA’s Enforcement Report: May 4, 202234. FDA terminated the recall: Sep 22, 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-0789-2022 (April 12, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0789-2022 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