NDC 57664-047
Lisdexamfetamine Dimesylate 20 mg capsule
On the label: Caraco Pharmaceutical Laboratories, Ltd..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ohm Laboratories Inc. | New Brunswick, NJ, United States | Makes it | No problems foundOct 31, 2024 · 22 inspections |
Recalls
- Oct 28, 2025 · Class II · Sun Pharmaceutical Industries Inc
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.
Lots: Lot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026. - Oct 28, 2025 · Class II · Sun Pharmaceutical Industries Inc
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.
Lots: Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026. - Oct 28, 2025 · Class II · Sun Pharmaceutical Industries Inc
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.
Lots: Lot #: AD42470, Expiry: 2/28/2026; AD48708, Expiry:4/30/2026. - Oct 28, 2025 · Class II · Sun Pharmaceutical Industries Inc
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.
Lots: Lot #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026. - Oct 28, 2025 · Class II · Sun Pharmaceutical Industries Inc
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.
Lots: Lot #:AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026. - Oct 28, 2025 · Class II · Sun Pharmaceutical Industries Inc
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.
Lots: Lot #: AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026. - Oct 28, 2025 · Class II · Sun Pharmaceutical Industries Inc
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.
Lots: Lot #: AD48712, Expiry: 4/30/2026; AD50898, Expiry: 5/31/2026. - Jun 16, 2025 · Class II · Sun Pharmaceutical Industries Inc
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).
Lots: Lot # AD42648, Exp 02/28/2026
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lisdexamfetamine: every company that makes it
- Form
- capsule, oral
- Strength
- 20 mg
- Approval
- ANDA ANDA214484
- On the market since
- Aug 25, 2023
- Package NDCs
57664-047-88- Official label
- DailyMed (National Library of Medicine), updated Jul 7, 2026
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