Why it was recalled
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.
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.
Lot numbers, UPCs & expiration codes
Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.
Where it was sold
U.S Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0145-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 28, 2025
- FDA report date
- Nov 5, 2025
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0145-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97874
- Address
- 2 Independence Way
- Code information
- Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026.
- Postal code
- 08540-6620
- Report date
- Nov 5, 2025
- Product type
- Drugs
- Recall number
- D-0145-2026
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S Nationwide.
- Recall initiation date
- Oct 28, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 30, 2025