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  3. Recall Enforcement Event ID: 97874

Recall Enforment Report D-0145-2026

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by SUN PHARMACEUTICAL INDUSTRIES INC, originally initiated on 10-28-2025 for the product Lisdexamfetamine Dimesylate Capsules, 20 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 57664-047-88. The product was recalled due to 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.. 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-0145-202610-28-202511-05-2025Class IIN/ALisdexamfetamine Dimesylate Capsules, 20 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 57664-047-88.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.Ongoing
D-0146-202610-28-202511-05-2025Class IIN/ALisdexamfetamine Dimesylate Capsules, 30 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 57664-048-88.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.Ongoing
D-0147-202610-28-202511-05-2025Class IIN/ALisdexamfetamine Dimesylate Capsules, 40 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 57664-049-88.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.Ongoing
D-0150-202610-28-202511-05-2025Class IIN/ALisdexamfetamine Dimesylate Capsules, 70 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 57664-052-88.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.Ongoing
D-0144-202610-28-202511-05-2025Class IIN/ALisdexamfetamine 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.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.Ongoing
D-0148-202610-28-202511-05-2025Class IIN/ALisdexamfetamine Dimesylate Capsules, 50 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 57664-050-88.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.Ongoing
D-0149-202610-28-202511-05-2025Class IIN/ALisdexamfetamine Dimesylate Capsules, 60 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 57664-051-88.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.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
57664-046Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-047Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-048Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-049Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-050Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-051Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-052Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-083Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateTablet, ChewableOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-084Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateTablet, ChewableOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-085Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateTablet, ChewableOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-086Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateTablet, ChewableOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-087Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateTablet, ChewableOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
57664-088Lisdexamfetamine Dimesylate Lisdexamfetamine DimesylateTablet, ChewableOralSun Pharmaceutical Industries, Inc.Human Prescription Drug