Lisdexamfetamine Dimesylate Capsule
FDA Recall NDC 57664-049
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 8 recorded enforcement report(s) associated with Lisdexamfetamine Dimesylate (NDC 57664-049). A significant event, classified as Class II, was initiated on Oct 28, 2025 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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.
Oct 28, 2025
Nov 05, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97874
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide.
Product Description
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.
Batch or Lot Expiration Information
Lot# : AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.
Affected Packages Involved in this Recall
57664-047-88Product
57664-046-88Product
57664-048-88Product
57664-049-88Product
57664-050-88Product
57664-051-88Product
57664-052-88Product
57664-083-88Product
57664-084-88Product
57664-085-88Product
57664-086-88Product
57664-087-88Product
57664-088-88Product
Class II Ongoing
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.
Oct 28, 2025
Nov 05, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97874
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide.
Product Description
Lisdexamfetamine 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.
Batch or Lot Expiration Information
Lot# : AD42470, Expiry: 2/28/2026; AD48708, Expiry:4/30/2026.
Affected Packages Involved in this Recall
57664-047-88Product
57664-046-88Product
57664-048-88Product
57664-049-88Product
57664-050-88Product
57664-051-88Product
57664-052-88Product
57664-083-88Product
57664-084-88Product
57664-085-88Product
57664-086-88Product
57664-087-88Product
57664-088-88Product
Class II Ongoing
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.
Oct 28, 2025
Nov 05, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97874
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide.
Product Description
Lisdexamfetamine 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.
Batch or Lot Expiration Information
Lot# : AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026.
Affected Packages Involved in this Recall
57664-047-88Product
57664-046-88Product
57664-048-88Product
57664-049-88Product
57664-050-88Product
57664-051-88Product
57664-052-88Product
57664-083-88Product
57664-084-88Product
57664-085-88Product
57664-086-88Product
57664-087-88Product
57664-088-88Product
Class II Ongoing
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.
Oct 28, 2025
Nov 05, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97874
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide.
Product Description
Lisdexamfetamine 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.
Batch or Lot Expiration Information
Lot# : AD48712, Expiry: 4/30/2026; AD50898, Expiry: 5/31/2026.
Affected Packages Involved in this Recall
57664-047-88Product
57664-046-88Product
57664-048-88Product
57664-049-88Product
57664-050-88Product
57664-051-88Product
57664-052-88Product
57664-083-88Product
57664-084-88Product
57664-085-88Product
57664-086-88Product
57664-087-88Product
57664-088-88Product
Class II Ongoing
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.
Oct 28, 2025
Nov 05, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97874
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide.
Product Description
Lisdexamfetamine 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.
Batch or Lot Expiration Information
Lot# :AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026.
Affected Packages Involved in this Recall
57664-047-88Product
57664-046-88Product
57664-048-88Product
57664-049-88Product
57664-050-88Product
57664-051-88Product
57664-052-88Product
57664-083-88Product
57664-084-88Product
57664-085-88Product
57664-086-88Product
57664-087-88Product
57664-088-88Product
Class II Ongoing
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.
Oct 28, 2025
Nov 05, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97874
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide.
Product Description
Lisdexamfetamine 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.
Batch or Lot Expiration Information
Lot# : AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026.
Affected Packages Involved in this Recall
57664-047-88Product
57664-046-88Product
57664-048-88Product
57664-049-88Product
57664-050-88Product
57664-051-88Product
57664-052-88Product
57664-083-88Product
57664-084-88Product
57664-085-88Product
57664-086-88Product
57664-087-88Product
57664-088-88Product
Class II Ongoing
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.
Oct 28, 2025
Nov 05, 2025
N/A
Recall Profile & Regulatory Data
Event ID
97874
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S Nationwide.
Product Description
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.
Batch or Lot Expiration Information
Lot# : AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026.
Affected Packages Involved in this Recall
57664-047-88Product
57664-046-88Product
57664-048-88Product
57664-049-88Product
57664-050-88Product
57664-051-88Product
57664-052-88Product
57664-083-88Product
57664-084-88Product
57664-085-88Product
57664-086-88Product
57664-087-88Product
57664-088-88Product
Class II Ongoing
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).
Jun 16, 2025
Jul 23, 2025
5,448 bottles
Recall Profile & Regulatory Data
Event ID
97092
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Product Description
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
Batch or Lot Expiration Information
Lot# AD42648, Exp 02/28/2026
Affected Packages Involved in this Recall
57664-047-88Product
57664-046-88Product
57664-048-88Product
57664-049-88Product
57664-050-88Product
57664-051-88Product
57664-052-88Product
57664-083-88Product
57664-084-88Product
57664-085-88Product
57664-086-88Product
57664-087-88Product
57664-088-88Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
