Why it was recalled
Presence of foreign substance: Presence of Benzene.
Product description
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 numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the U.S
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0294-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 5, 2025
- FDA report date
- Apr 2, 2025
- Quantity
- 244,412 Cartons; 30 sachets /Carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Strides Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0294-2025, exactly as published.
Show all FDA fields
- City
- Chestnut Ridge
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 96412
- Address
- 1 Ram Ridge Rd
- Code information
- 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.
- Postal code
- 10977-6714
- Report date
- Apr 2, 2025
- Product type
- Drugs
- Recall number
- D-0294-2025
- Classification
- Class II
- Recalling firm
- Strides Pharma, Inc.
- Product quantity
- 244,412 Cartons; 30 sachets /Carton
- Reason for recall
- Presence of foreign substance: Presence of Benzene.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the U.S
- Recall initiation date
- Mar 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 25, 2025