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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

Teva Testosterone Gel Recalled for Incorrect Thickness (Viscosity)

Agency Publication Date: November 29, 2023
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Summary

Teva Pharmaceuticals USA is recalling one lot of its Testosterone Gel (1.62%) because the product's thickness, or viscosity, was found to be out of the required specification. This prescription medication is sold in cartons containing 30 individual unit-dose packets. No injuries or medical issues have been reported in connection with this recall.

Risk

If the gel is too thick or too thin, it may not be absorbed correctly by the skin or could be difficult for the patient to dispense properly from the packet. While no injuries have been reported, incorrect thickness can affect how the medication is delivered.

What You Should Do

  1. The recalled product is Teva brand Testosterone Gel, 1.62% (Alcohol 80% v/v), packaged in cartons of 30 unit-dose packets (NDC 0591-2926-30).
  2. Check your medication carton and packets for lot number 100029472 with an expiration date of February 29, 2024.
  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 Teva Pharmaceuticals USA, Inc. for further instructions.
  4. 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: Testosterone Gel, 1.62% (Alcohol 80% v/v)
Variants: 1.62%, Alcohol 80% v/v, 30 unit-dose packets per carton, Rx only
Lot Numbers:
100029472 (Exp. 2/29/2024)
NDC:
0591-2926-30

Packaged by Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93409
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA, Inc
Sold By: pharmacies; healthcare providers
Manufactured In: United States
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.