Testosterone Gel 1% — Class II drug recall D-0294-2025
Ongoing recall by Strides Pharma, Inc., reported 2025-04-02, distributed nationwide. Presence of foreign substance: Presence of Benzene.
| Recall number | D-0294-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Strides Pharma, Inc., Chestnut Ridge, NY, United States |
| Recall initiated | 2025-03-05 |
| Classified | 2025-03-25 |
| Reported by FDA | 2025-04-02 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination |
| NDC | 64380-0151, 64380-0151-01, 64380-0151-02, 64380-0152, 64380-0152-01, 64380-0152-02 |
| Lot numbers | 5501103A, 5501237A, 5501238A, 5501278A, 5501280A, 5501342A, 5501372A, 5501496A, 5501499A, 5501580A, 5501582A, 5501653A, 5501656A, 5501770A, 5501842A, 5501868A, 5501882A, 5501957A, 5502001A, 5502033A, 5502112A, 5502115A, 5502180A, 5502181A, APR-25, APR-26, AUG-25, AUG-26, DEC-25, FEB-26, JAN-26, JUL-25, JUL-26, JUN-25, MAR-25, MAY-25, MAY-26, NOV-26, OCT-25, OCT-26 and 1 more |
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
Reason for recall
Presence of foreign substance: Presence of Benzene.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0294-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.