Drug recall
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM…
FDA recall event 97874 · Class II · SUN PHARMACEUTICAL INDUSTRIES INC
Key facts
| Event ID | 97874 |
|---|---|
| Recall numbers | D-0144-2026, D-0145-2026, D-0146-2026, D-0147-2026, D-0148-2026, D-0149-2026, D-0150-2026 |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Product type | Drugs |
| Products | 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…, 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…, 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…, 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…, 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… and 2 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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… |
| Initiation date | Oct 28, 2025 |
| Report date | Nov 5, 2025 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3013472760 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: