RecallRadar

FDA Drug recall D-0144-2026

Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Di…

On 2025-11-05 the FDA classified a Class II recall of Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Di… by Sun Pharmaceutical Industries, citing 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 Lisdexamf….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0144-2026
ClassificationClass II
Statusongoing
Initiated2025-10-28
Published2025-11-05
Last updated2026-09-13 11:52 UTC
CompanySun Pharmaceutical Industries
DistributionUS

Product

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.

Reason

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.

Identifiers

ndc57664-047-88
ndc57664-046-88
ndc57664-048-88
ndc57664-049-88
ndc57664-050-88
ndc57664-051-88
ndc57664-052-88
ndc57664-083-88
ndc57664-084-88
ndc57664-085-88
ndc57664-086-88
ndc57664-087-88
ndc57664-088-88
code_infoLot #: AD42468, Expiry: 2/28/2026; AD48705, Expiry: 4/30/2026.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0144-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.