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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Testosterone Gel Recalled for Benzene Contamination

Agency Publication Date: March 25, 2025
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Summary

Strides Pharma, Inc. is recalling approximately 440,364 cartons of Testosterone Gel 1% (2.5 grams and 5 grams) because of the presence of benzene, a foreign substance. The recall includes 195,952 cartons of the 2.5 gram dose and 244,412 cartons of the 5 gram dose, each containing 30 unit-dose packets per carton. This prescription-only medication is used for testosterone replacement therapy. Benzene is a known human carcinogen that can pose long-term health risks if absorbed into the body. Consumers should check their cartons for specific lot numbers and expiration dates. If you have any remaining medication from the affected lots, you should contact your doctor or pharmacist to discuss alternative treatments.

Risk

The product contains benzene, which is classified as a human carcinogen. Exposure to benzene can potentially occur through skin absorption from the topical gel, and long-term exposure is associated with an increased risk of developing cancer and other serious blood disorders.

What You Should Do

  1. The recalled products are Testosterone Gel 1% in 2.5 gram (NDC 64380-151-02) and 5 gram (NDC 64380-152-02) unit-dose packets, sold in cartons containing 30 sachets each.
  2. Check the lot number and expiration date printed on the side of your medication carton or on the individual packets. See the Affected Products section below for the full list of affected codes.
  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 Strides Pharma, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding consumer safety.

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%, 2.5 grams (30 Unit-dose packets/carton)
Variants: 2.5 grams, Unit-dose packets, Rx only
Lot Numbers:
5501127A (Exp Apr-25)
5501236A (Exp Apr-25)
5501341A (Exp Jun-25)
5501406A (Exp Jul-25)
5501408A (Exp Aug-25)
5501516A (Exp Sep-25)
5501568A (Exp Oct-25)
5501829A (Exp Mar-26)
5502000A (Exp Jul-26)
5502004A (Exp Aug-26)
5502005A (Exp Aug-26)
5502092A (Exp Oct-26)
5502217A (Exp Dec-26)
5502262A (Exp Jan-27)
NDC:
64380-151-02

Quantity: 195,952 Cartons

Product: Testosterone Gel 1%, 5 grams (30 Unit-dose packets/carton)
Variants: 5 grams, Unit-dose packets, Rx only
Lot Numbers:
5501103A (Exp Mar-25)
5501237A (Exp Apr-25)
5501238A (Exp Apr-25)
5501278A (Exp May-25)
5501280A (Exp Jun-25)
5501342A (Exp Jun-25)
5501372A (Exp Jul-25)
5501496A (Exp Aug-25)
5501499A (Exp Sep-25)
5501580A (Exp Oct-25)
5501582A (Exp Dec-25)
5501653A (Exp Jan-26)
5501656A (Exp Jan-26)
5501770A (Exp Feb-26)
5501842A (Exp Apr-26)
5501868A (Exp Apr-26)
5501882A (Exp Apr-26)
5501957A (Exp May-26)
5502001A (Exp Jul-26)
5502033A (Exp Aug-26)
5502112A (Exp Oct-26)
5502115A (Exp Oct-26)
5502180A (Exp Nov-26)
5502181A (Exp Nov-26)
NDC:
64380-152-02

Quantity: 244,412 Cartons

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96412
Status: Active
Manufacturer: Strides Pharma, Inc.
Sold By: Pharmacies; Hospitals; Authorized Drug Distributors
Manufactured In: United States
Units Affected: 2 products (195,952 Cartons; 30 sachets/Carton.; 244,412 Cartons; 30 sachets /Carton)
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.