Why it was recalled
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).
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
Lot numbers, UPCs & expiration codes
Lot # AD42648, Exp 02/28/2026
Where it was sold
Recalled units were distributed to 17 distributors who may have further distributed the product 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-0516-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 16, 2025
- FDA report date
- Jul 23, 2025
- Quantity
- 5,448 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0516-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97092
- Address
- 2 Independence Way
- Code information
- Lot # AD42648, Exp 02/28/2026
- Postal code
- 08540-6620
- Report date
- Jul 23, 2025
- Product type
- Drugs
- Recall number
- D-0516-2025
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
- Recall initiation date
- Jun 16, 2025
- Initial firm notification
- Letter
- Center classification date
- Jul 11, 2025