Testosterone Gel 1% recall
FDA recall D-0294-2025 · initiated Mar 5, 2025
Strides Pharma, Inc. recalled Testosterone Gel 1% in Mar 2025 — an FDA Class II recall (D-0294-2025) because Presence of foreign substance: Presence of Benzene.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of foreign substance: Presence of Benzene.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 244,412 Cartons; 30 sachets /Carton
Details
- Product
- 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
- Recalling company
- Strides Pharma Intl
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S
- Initiated
- Mar 5, 2025
- FDA report date
- Apr 2, 2025
Frequently asked
- Was Testosterone Gel 1% recalled?
- Strides Pharma, Inc. recalled Testosterone Gel 1% in Mar 2025 — an FDA Class II recall (D-0294-2025) because Presence of foreign substance: Presence of Benzene. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Testosterone Gel 1% recalled?
- Per the FDA enforcement record, the reason for recall D-0294-2025 was: Presence of foreign substance: Presence of Benzene.
- Is a recalled Testosterone Gel 1% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Testosterone Gel 1% are affected?
- Distributed: Nationwide in the U.S. The recall covers these lots — 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;…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0294-2025.