FDA Recall D-0294-2025

Strides Pharma, Inc. · Chestnut Ridge, NY

Class II Ongoing 435 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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.

Quantity: 244,412 Cartons; 30 sachets /Carton

Reason for recall

Presence of foreign substance: Presence of Benzene.

Recall record

Recall number: D-0294-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the U.S
Recall initiated: 2025-03-05
Classified by FDA Center: 2025-03-25
FDA published: 2025-04-02
Recalling firm: Strides Pharma, Inc.
Firm location: Chestnut Ridge, NY

Drug identification

Brand name(s): TESTOSTERONE
Generic name(s): TESTOSTERONE
Manufacturer(s): Strides Pharma Science Limited
NDC(s): 64380-151, 64380-152
Route(s): TRANSDERMAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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