Recalls / Class II
Class IID-0516-2025
Product
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
- Brand name
- Lisdexamfetamine Dimesylate
- Generic name
- Lisdexamfetamine Dimesylate
- Active ingredient
- Lisdexamfetamine Dimesylate
- Route
- Oral
- NDCs
- 57664-046, 57664-047, 57664-048, 57664-049, 57664-050, 57664-051, 57664-052, 57664-083, 57664-084, 57664-085 +3 more
- FDA application
- ANDA214484
- Affected lot / code info
- Lot # AD42648, Exp 02/28/2026
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).
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 5,448 bottles
- Distribution pattern
- Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Timeline
- Recall initiated
- 2025-06-16
- FDA classified
- 2025-07-11
- Posted by FDA
- 2025-07-23
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0516-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.