The Recall Desk
HighFDA (Drugs)·D-0294-2025·Announced 2025-04-02

Testosterone Gel Recalled Nationwide Due to Benzene Contamination

Strides Pharma is recalling Testosterone Gel 1% nationwide due to the presence of benzene, a toxic substance. Patients should contact their healthcare provider about alternative treatment options.

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: This is a risk-of-harm pharmaceutical product (medication contaminated with benzene, a toxic substance) where no illnesses or injuries have been reported, aligning with the 'High' severity criteria for products with potential harm but no reported adverse events.

Plain-English summary

Strides Pharma, Inc. is recalling Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets (NDC 64380-152-02) due to the presence of benzene, a toxic foreign substance detected in the product.

The affected product was distributed nationwide in the United States. A total of 244,412 cartons are included in this recall. The affected lot numbers include 5501103A (March 2025), 5501237A and 5501238A (April 2025), 5501278A (May 2025), 5501280A and 5501342A (June 2025), 5501372A (July 2025), 5501496A (August 2025), 5501499A (September 2025), 5501580A (October 2025), 5501582A (December 2025), 5501653A and 5501656A (January 2026), 5501770A (February 2026), 5501842A, 5501868A, and 5501882A (April 2026), 5501957A (May 2026), 5502001A (July 2026), 5502033A (August 2026), 5502112A and 5502115A (October 2026), and 5502180A and 5502181A (November 2026).

Patients currently using this testosterone gel should stop immediately and contact their healthcare provider to discuss alternative treatment options. Healthcare providers should be aware of this recall when advising patients on testosterone replacement therapy. Anyone who has taken this product and experienced any adverse health effects should report the incident to the FDA.

The recalled product

Product
TESTOSTERONE (TESTOSTERONE)
Brand
TESTOSTERONE
Manufacturer
Strides Pharma, Inc.
Category
Drug — Testosterone / Hormone Replacement
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 #: 5501103A
  • Exp Mar-25
  • 5501237A
  • 5501238A
  • Exp Apr-25
  • 5501278A
  • Exp May-25
  • 5501280A
  • 5501342A
  • Exp Jun-25
  • 5501372A
  • Exp Jul-25
  • 5501496A
  • Exp Aug-25
  • 5501499A
  • Exp Sep-25
  • 5501580A
  • Exp Oct-25
  • 5501582A
  • Exp Dec-25

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

See all →