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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Lannett Triamterene and Hydrochlorothiazide Recalled for Impurity Issues

Agency Publication Date: January 17, 2023
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Summary

Lannett Company Inc. is recalling approximately 25,680 bottles of Triamterene and Hydrochlorothiazide Capsules (37.5 mg/25 mg), a prescription medication used to treat high blood pressure and fluid retention. The recall was issued because the medication failed quality tests due to levels of impurities and degradation that exceeded safety specifications. There have been no reported incidents or injuries associated with these specific lots.

Risk

The presence of impurities or degradation products that exceed approved limits can compromise the safety and effectiveness of the medication. Taking medication that has degraded may not properly control blood pressure or swelling as intended.

What You Should Do

  1. The recall affects Triamterene and Hydrochlorothiazide Capsules (37.5 mg/25 mg) distributed by Lannett Company, Inc., sold in both 100-count and 1,000-count bottles.
  2. Check your prescription bottle for NDC numbers 0527-1632-10 (1,000 count) or 0527-1632-01 (100 count) and lot numbers 20256318A, 20256321A, 21000238A, 21000279A, or 20256320A with expiration dates in December 2022 or January 2023.
  3. If you have health concerns regarding this medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Lannett Company Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information.

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: Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg)
Variants: 37.5 mg/25 mg, 1,000 Capsules per bottle
Lot Numbers:
20256318A (12/2022)
20256321A (12/2022)
21000238A (01/2023)
NDC:
0527-1632-10

Recall #: D-0160-2023; Quantity: 5,640 bottles

Product: Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg)
Variants: 37.5 mg/25 mg, 100 Capsules per bottle, 1,000 Capsules per bottle
Lot Numbers:
21000279A (exp 01/2023)
20256320A (12/2022)
NDC:
0527-1632-01
0527-1632-10

Recall #: D-0161-2023; Quantity: 20,040 bottles

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91142
Status: Resolved
Manufacturer: Lannett Company Inc.
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2 products (5,640 bottles; 20,040 bottles)
Distributed To: Nationwide

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.