FDA Recall D-0144-2026

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class II Ongoing 198 days on record

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

Product

Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-046-88.

Lot / code: Lot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026.

Quantity: N/A

Reason for recall

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

Recall record

Recall number: D-0144-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S Nationwide.
Recall initiated: 2025-10-28
Classified by FDA Center: 2025-10-30
FDA published: 2025-11-05
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): LISDEXAMFETAMINE DIMESYLATE
Generic name(s): LISDEXAMFETAMINE DIMESYLATE
Manufacturer(s): Sun Pharmaceutical Industries, Inc.
NDC(s): 57664-046, 57664-047, 57664-048, 57664-049, 57664-050, 57664-051, 57664-052, 57664-083, 57664-084, 57664-085, 57664-086, 57664-087, 57664-088
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.

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