The Recall Desk
HighFDA (Drugs)·D-0293-2025·Announced 2025-04-02

Strides Pharma Testosterone Gel Recalled Due to Benzene Contamination

Strides Pharma is recalling Testosterone Gel 1% (195,952 cartons nationwide) due to benzene contamination. Consumers using affected lots should immediately contact their healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with benzene contamination, a known carcinogenic hazard. Although no illnesses or injuries have been reported, the presence of benzene in a transdermal product presents significant potential for harm.

Plain-English summary

Strides Pharma, Inc. is recalling Testosterone Gel 1%, a prescription medication sold in 2.5-gram unit-dose packets. The product was distributed nationwide in the United States.

The recall was initiated due to the presence of benzene, a foreign substance that should not be present in the product.

Approximately 195,952 cartons are affected. The recall includes the following 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), and 5502262A (Exp Jan-27).

Consumers currently using this product should stop immediately and contact their healthcare provider. Healthcare providers and pharmacists should verify that prescriptions are not being filled with affected lot numbers.

The recalled product

Product
TESTOSTERONE (TESTOSTERONE)
Brand
TESTOSTERONE
Manufacturer
Strides Pharma, Inc.
Category
Drug — Hormone / Transdermal
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #: 5501127A
  • 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
  • 5502005A
  • Exp Aug-26

UPCs (2)

  • 0364380151012
  • 0364380152019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Strides Pharma, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · TESTOSTERONE

Same manufacturer · Strides Pharma, Inc.

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Same hazard · benzene

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