Lisdexamfetamine Dimesylate Capsules — Class II drug recall D-0149-2026
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2025-11-05, distributed nationwide. Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysi
| Recall number | D-0149-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2025-10-28 |
| Classified | 2025-10-30 |
| Reported by FDA | 2025-11-05 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 57664-0046, 57664-0046-88, 57664-0047, 57664-0047-88, 57664-0048, 57664-0048-88, 57664-0049, 57664-0049-88, 57664-0050, 57664-0050-88, 57664-0051, 57664-0051-88, 57664-0052, 57664-0052-88, 57664-0083, 57664-0083-88, 57664-0084, 57664-0084-88, 57664-0085, 57664-0085-88, 57664-0086, 57664-0086-88, 57664-0087, 57664-0087-88, 57664-0088 and 1 more |
| Lot numbers | AD48711, AD50896 |
| Expiration dates | 2026-04-30, 2026-05-31 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0149-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.