Recall Enforment Report D-0294-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Strides Pharma, Inc., originally initiated on 03-05-2025 for the 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 The product was recalled due to presence of foreign substance: presence of benzene.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0294-202503-05-202504-02-2025Class II244,412 Cartons; 30 sachets /CartonTestosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02Presence of foreign substance: Presence of Benzene.Ongoing
D-0293-202503-05-202504-02-2025Class II195,952 Cartons; 30 sachets/Carton.Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02Presence of foreign substance: Presence of Benzene.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
64380-151Testosterone TestosteroneGelTransdermalStrides Pharma Science LimitedHuman Prescription Drug
64380-152Testosterone TestosteroneGelTransdermalStrides Pharma Science LimitedHuman Prescription Drug