RecallRadar

FDA Drug recall D-0516-2025

Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, D…

On 2025-07-23 the FDA classified a Class II recall of Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, D… by Sun Pharmaceutical Industries, citing 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).

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0516-2025
ClassificationClass II
Statusongoing
Initiated2025-06-16
Published2025-07-23
Last updated2026-09-13 11:52 UTC
CompanySun Pharmaceutical Industries
DistributionUS

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

Reason

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).

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 # AD42648, Exp 02/28/2026

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-0516-2025%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.