Recalls / Class II
Class IID-0147-2026
Product
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.
- 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 #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026.
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.
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
- N/A
- Distribution pattern
- U.S Nationwide.
Timeline
- Recall initiated
- 2025-10-28
- FDA classified
- 2025-10-30
- Posted by FDA
- 2025-11-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0147-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.