FDA Recall D-0516-2025

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class II Ongoing 332 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, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88

Lot / code: Lot # AD42648, Exp 02/28/2026

Quantity: 5,448 bottles

Reason for recall

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).

Recall record

Recall number: D-0516-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Recall initiated: 2025-06-16
Classified by FDA Center: 2025-07-11
FDA published: 2025-07-23
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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