FDA Recall D-0384-2026

Rising Pharma Holding, Inc. · East Brunswick, NJ

Class II Ongoing 72 days on record

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

Product

Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.

Lot / code: Lot #: 1TM0524003A, Exp. Date 09/2026.

Quantity: 1200 bottles

Reason for recall

Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing

Recall record

Recall number: D-0384-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the U.S
Recall initiated: 2026-03-03
Classified by FDA Center: 2026-03-04
FDA published: 2026-03-11
Recalling firm: Rising Pharma Holding, Inc.
Firm location: East Brunswick, NJ

Drug identification

Brand name(s): TEMOZOLOMIDE
Generic name(s): TEMOZOLOMIDE
Manufacturer(s): Rising Pharma Holdings, Inc.
NDC(s): 16571-816, 16571-817, 16571-818, 16571-819, 16571-820, 16571-821
Route(s): ORAL

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.

‹ All recalls