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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Preferred Pharmaceuticals Losartan Potassium & HCTZ Recalled for Impurity

Agency Publication Date: May 24, 2022
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Summary

Preferred Pharmaceuticals, Inc. has recalled Losartan Potassium and hydrochlorothiazide (HCTZ) 50mg/12.5 mg tablets because they contain an AZIDO impurity above acceptable safety limits. The recall affects 78 units, consisting of 31 bottles of 90 tablets (Lot: K1721D), 5 bottles of 90 tablets (K1021E), 47 Bottles of 30 Tabs (K1721E), and 35 Bottles of 30 Tabs (H3021Q). AZIDO is a chemical compound that can potentially increase the risk of cancer over long-term exposure. No injuries or illnesses have been reported to date regarding this recall.

Risk

The medication was found to contain levels of an AZIDO impurity that exceed the FDA's acceptable safety thresholds. While there is no immediate acute health risk, long-term exposure to this impurity is associated with an increased risk of developing cancer.

What You Should Do

  1. This recall affects Losartan Potassium and hydrochlorothiazide (HCTZ) 50mg/12.5 mg tablets sold in 30-count and 90-count bottles under the Preferred Pharmaceuticals, Inc. label.
  2. Check your medication bottle for NDC numbers 68788-7758-09 (90-count) or 68788-7758-03 (30-count) and look for lot numbers K1721D, K1021E, K1721E, or H3021Q with expiration dates between February and July 2023.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Losartan Potassium & HCTZ Tablets 50mg/12.5 mg (90 tablets)
Variants: 50mg/12.5 mg, Tablet, 90 count
Lot Numbers:
K1721D (Exp 4/30/2023)
K1021E (Exp 7/31/2023)
NDC:
68788-7758-09

31 bottles of lot K1721D and 5 bottles of lot K1021E affected.

Product: Losartan Potassium & HCTZ Tablets 50mg/12.5 mg (30 tablets)
Variants: 50mg/12.5 mg, Tablet, 30 count
Lot Numbers:
K1721E (Exp 4/30/2023)
H3021Q (Exp 2/28/2023)
NDC:
68788-7758-03

47 bottles of lot K1721E and 35 bottles of lot H3021Q affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90148
Status: Resolved
Manufacturer: Preferred Pharmaceuticals, Inc.
Sold By: Retail Pharmacies
Manufactured In: United States
Units Affected: 2 products (31 bottles of 90 tables (Lot: K1721D); 5 bottles of 90 tablets (K1021E).; 47 Bottles of 30 Tabs (K1721E); 35 Bottles of 30 Tabs (H3021Q).)
Distributed To: Florida, California

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.