United StatesLisdexamfetamine dimesylate capsules (10 mg–70 mg) in 100-count prescription bottles manufactured by OHM Laboratories and distributed by Sun Pharmaceutical Industries (NDCs 57664-046-88 through 57664-052-88) are being recalled in the U.S.; affected lots include AD42468–AD42470, AD48705–AD48712, AD50894–AD50898 with expirations 2/28/2026–5/31/2026. The recall was issued after out-of-specification results in a 12-month stability dissolution test (25°C, 60% RH).
What's being recalled
Lisdexamfetamine Dimesylate Capsules, 10 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 57664-046-88.
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.
Lisdexamfetamine Dimesylate Capsules, 30 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 57664-048-88.
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.
Lisdexamfetamine Dimesylate Capsules, 50 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 57664-050-88.
Lisdexamfetamine Dimesylate Capsules, 60 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 57664-051-88.
Lisdexamfetamine Dimesylate Capsules, 70 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 57664-052-88.
Recalling firm: Sun Pharmaceutical Industries Inc, Princeton, NJ, United States.
How to identify it
Lot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026. Lot #: AD42469, Expiry: 2/28/2026; AD48707, Expiry:4/30/2026. Lot #: AD42470, Expiry: 2/28/2026; AD48708, Expiry:4/30/2026. Lot #: AD48709, Expiry: 4/30/2026; AD50894, Expiry: 5/31/2026. Lot #:AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026. Lot #: AD48711, Expiry: 4/30/2026; AD50896, Expiry: 5/31/2026. Lot #: AD48712, Expiry: 4/30/2026; AD50898, Expiry: 5/31/2026.
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)