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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/Over-the-Counter

Genexa Cough and Chest Congestion Recalled for Crystallization

Agency Publication Date: November 1, 2024
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Summary

Denison Pharmaceuticals, LLC has recalled 177,696 bottles of Genexa Adult and Kids' Cough and Chest Congestion medications (dextromethorphan HBr and guaifenesin) due to a texture change. Testing identified crystallization inside the bottles, resulting in a chunky, grainy, or sandy consistency. This crystallization means the medicine is no longer uniform, which may affect how the dosage is delivered.

Risk

The presence of crystals or chunky substances in the liquid medication can cause an inconsistent mixture, potentially leading to an inaccurate dose of the active ingredients. No injuries or adverse incidents have been reported to date.

What You Should Do

  1. This recall affects Genexa Adult Cough and Chest Congestion (UPC 850015736155) and Genexa Kids' Cough and Chest Congestion (UPC 850015736018) sold in 4 oz bottles.
  2. For Genexa Adult Cough and Chest Congestion, check for lot numbers 0104V (Exp 07/2025) or 0106V (Exp 09/2024).
  3. For Genexa Kids' Cough and Chest Congestion, check for lot numbers 0813V (Exp 06/2025) or 0103V (Exp 03/2025).
  4. 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.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Genexa Adult Cough and Chest Congestion (4 oz)by Genexa
Variants: Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg
UPC Codes:
850015736155
Lot Numbers:
0104V (Exp 07/2025)
0106V (Exp 09/2024)
NDC:
69676-0077-9
Product: Genexa Kids' Cough and Chest Congestion (4 oz)by Genexa
Variants: Dextromethorphan HBr USP 5mg, Guaifenesin USP 100 mg
UPC Codes:
850015736018
Lot Numbers:
0813V (Exp 06/2025)
0103V (Exp 03/2025)
NDC:
69676-0077-9

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95430
Status: Active
Manufacturer: Denison Pharmaceuticals, LLC
Sold By: Retailers
Manufactured In: United States
Units Affected: 2 products (72,648 bottles; 105,048 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.