Strides Pharma Recalls Testosterone Gel Due to Benzene Contamination
Strides Pharma recalls specific lots of Testosterone Gel 1% due to the presence of benzene, a known carcinogen. Check your lot numbers immediately.
Stop using this now
Presence of foreign substance: Presence of Benzene.
Contact the company
What happened, in plain English
Strides Pharma Inc. is recalling Testosterone Gel 1% because it contains benzene, a foreign substance. The recall affects 244,412 cartons distributed nationwide in the U.S. Benzene is a known human carcinogen that can be absorbed through the skin. Read more at govinfonow.com/recall/32246-strides-pharma-recalls-testosterone-gel-due-to-benzene-contamination.
Source Summary by GovInfoNow · govinfonow.com/recall/32246-strides-pharma-recalls-testosterone-gel-due-to-benzene-contamination · Updated October 9, 2026 · FDA enforcement record: FDA #D-0294-2025
Cite this page
“Strides Pharma Recalls Testosterone Gel Due to Benzene Contamination.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32246-strides-pharma-recalls-testosterone-gel-due-to-benzene-contamination. Based on FDA recall #D-0294-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0294-2025%22&limit=1).
Why it’s dangerous
The gel contains benzene, which is a known human carcinogen. Because the product is applied to the skin, there is a risk of benzene being absorbed into the body during normal use.
Who’s affected
Patients prescribed Testosterone Gel 1% who purchased the recalled cartons from pharmacies or healthcare providers across the United States.
How to tell if you have this one
Check your carton for NDC 64380-152-02 and one of the following lot numbers: 5501103A (Exp Mar-25), 5501237A or 5501238A (Exp Apr-25), 5501278A (Exp May-25), 5501280A or 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 or 5501656A (Exp Jan-26), 5501770A (Exp Feb-26), 5501842A, 5501868A, or 5501882A (Exp Apr-26), 5501957A (Exp May-26), 5502001A (Exp Jul-26), 5502033A (Exp Aug-26), 5502112A or 5502115A (Exp Oct-26), or 5502180A or 5502181A (Exp Nov-26).
- Brand
Strides Pharma- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Nationwide in the U.S- NDC
64380-152-01, 64380-152-02, 64380-151-01, 64380-151-02
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0293-2025 | Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02; 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; 5502092A, Exp Oct-26; 5502217A, Exp Dec-26; 5502262A, Exp Jan-27 | 195,952 Cartons; 30 sachets/Carton. |
| D-0294-2025 | Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02; 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; 5501653A, 5501656A, Exp Jan-26; 5501770A, Exp Feb-26; 5501842A, 5501868A, 5501882A, Exp Apr-26; 5501957A, Exp May-26; 5502001A, Exp Jul-26; 5502033A, Exp Aug-26; 5502112A, 5502115A, Exp Oct-26; 5502180A, 5502181A, Exp Nov-26. | 244,412 Cartons; 30 sachets /Carton |
What to do — step by step
Stop using the gel immediately
Do not apply the recalled Testosterone Gel to your skin.
Contact your healthcare provider
Speak with your doctor or pharmacist about alternative treatments and how to return or dispose of the product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the U.S” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many cartons are being recalled?
The recall involves 244,412 cartons, with each carton containing 30 unit-dose packets (sachets).
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0294-2025 (March 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0294-2025 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.