Lisdexamfetamine 60 mg capsules failed dissolution testing at nine month stability
Lisdexamfetamine Dimesylate Capsules 60 mg are being recalled because an out of specification result was observed in dissolution testing at the nine month long term stability station. 5,448 bottles affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for an out-of-specification dissolution result found in stability testing, with no health consequence stated in the source.
Plain-English summary
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, prescription only, manufactured by OHM Laboratories of New Brunswick, New Jersey and distributed by Sun Pharmaceuticals, Inc. of Cranbury, New Jersey, NDC 57664-051-88, are being recalled. The action covers 5,448 bottles.
The stated reason is failed dissolution specifications: an out of specification result was observed in the dissolution test during analysis at the 9 month long term stability station at 25°C and 60% relative humidity. The FDA classified the action as Class II.
The affected lot is AD42648, expiring 02/28/2026. The recalled units were distributed to 17 distributors who may have further distributed them.
Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the distributor.
The recalled product
- Product
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
- Brand
- LISDEXAMFETAMINE DIMESYLATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Oral capsule
- Affected units
- 5,448
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # AD42648
- Exp 02/28/2026
Distribution
Distributed nationwide across the United States.
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