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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/Over-the-Counter

Major Pharmaceuticals Fexofenadine Tablets Recalled for Failed Impurities

Agency Publication Date: December 21, 2021
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Summary

The Harvard Drug Group is recalling 2,239 bottles of Major Pharmaceuticals Fexofenadine Hydrochloride Tablets (60 mg), a generic version of the allergy medication Allegra. This recall was initiated because the tablets failed to meet specifications for impurities and degradation, meaning the medication may have broken down over time. No incidents or injuries have been reported to date. Affected bottles contain 500 tablets each and were distributed nationwide.

Risk

When a medication fails impurity or degradation specifications, it means the active ingredient may have chemically broken down or contains unwanted substances. This can result in the medication being less effective at treating allergy symptoms or potentially causing unexpected side effects from the degradation products.

What You Should Do

  1. The recalled product is Major Pharmaceuticals Fexofenadine Hydrochloride Tablets (60 mg) sold in 500-count bottles with NDC 0904-6979-40.
  2. Check your bottle to see if it matches lot numbers H00005 (expiration 01/2022), H00006 (expiration 04/2022), or H00007 (expiration 07/2022).
  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: Fexofenadine Hydrochloride Tablets (500 tablets per bottle)by Major Pharmaceuticals
Variants: 60 mg
Lot Numbers:
H00005 (exp 01/2022)
H00006 (exp 04/2022)
H00007 (exp 07/2022)
NDC:
0904-6979-40

Distributed by Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88811
Status: Resolved
Manufacturer: The Harvard Drug Group
Sold By: Major Pharmaceuticals
Manufactured In: United States
Units Affected: 2,239 bottles
Distributed To: Nationwide

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.