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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

AbbVie Inc.: AndroGel (testosterone gel) Recalled for Potential Reduced Effectiveness

Agency Publication Date: November 3, 2017
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Summary

AbbVie Inc. is recalling approximately 568 units of AndroGel (testosterone gel) 1.62% in both metered-dose pumps and individual foil packets. This recall was initiated because the medication was exposed to temperatures outside of the recommended storage conditions for an extended period, which could affect how well the drug works. These products were distributed specifically in Arizona and include both the 88-gram pump and the 2.5-gram aluminum foil packets.

Risk

Prolonged exposure to temperatures outside the labeled range—known as temperature abuse—can degrade the active ingredient, potentially resulting in a loss of potency. This means the medication may not provide the intended dose of testosterone required for treatment.

What You Should Do

  1. Check your medication packaging to see if it matches the affected lots: for AndroGel 88g metered-dose pumps (NDC 0051-8462-33), look for lot 91122 with an expiration date of 01/2020.
  2. For AndroGel 2.5g aluminum foil packets (NDC 0051-8462-30), check for lot D60010A with an expiration date of 01/2019.
  3. Contact your healthcare provider or pharmacist immediately to discuss if you should continue using your current supply or if a replacement is necessary.
  4. Return any unused portions of the affected medication to your pharmacy for a refund and to ensure the product is properly disposed of.
  5. Contact AbbVie Inc. at their North Chicago headquarters for further instructions regarding this voluntary recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: AndroGel (testosterone gel) 1.62% (88 gm metered-dose pump)
Model:
NDC: 0051-8462-33
Recall #: D-0033-2018
Lot Numbers:
91122 (EXP. 01/2020)
Date Ranges: Expiration 01/2020
Product: AndroGel (testosterone gel) 1.62% (40.5mg in 2.5g aluminum foil packet)
Model:
NDC: 0051-8462-30
Recall #: D-0034-2018
Lot Numbers:
D60010A (EXP. 01/2019)
Date Ranges: Expiration 01/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78143
Status: Resolved
Manufacturer: AbbVie Inc.
Sold By: pharmacies
Manufactured In: United States
Units Affected: 2 products (520 pumps; 48 cartons (30 foil packets per carton))
Distributed To: Arizona

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 · 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.