Recalls / Class II
Class IID-0293-2025
Product
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
- Brand name
- Testosterone
- Generic name
- Testosterone
- Active ingredient
- Testosterone
- Route
- Transdermal
- NDCs
- 64380-151, 64380-152
- FDA application
- ANDA076744
- Affected lot / code info
- 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
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
- 195,952 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-0293-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.