Recalls / Class II
Class IID-0294-2025
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
- Brand name
- Testosterone
- Generic name
- Testosterone
- Active ingredient
- Testosterone
- Route
- Transdermal
- NDCs
- 64380-151, 64380-152
- FDA application
- ANDA076744
- Affected lot / code info
- 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.
Why it was recalled
Presence of foreign substance: Presence of Benzene.
Recalling firm
- Firm
- Strides Pharma, Inc.
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Ram Ridge Rd, N/A, Chestnut Ridge, New York 10977-6714
Distribution
- Quantity
- 244,412 Cartons; 30 sachets /Carton
- Distribution pattern
- Nationwide in the U.S
Timeline
- Recall initiated
- 2025-03-05
- FDA classified
- 2025-03-25
- Posted by FDA
- 2025-04-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0294-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.