Drug Enforcement D-0516-2025

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).

Status

Ongoing

Classification

Class II

Report Date

July 23, 2025

Termination Date

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Product Information

Product description
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
Product quantity
5,448 bottles
Reason for recall
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).
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Recalled units were distributed to 17 distributors who may have further distributed the product nationwide.

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0516-2025
Event ID
97092
Recall initiation date
June 16, 2025
Center classification date
July 11, 2025
Code info
Lot # AD42648, Exp 02/28/2026
More code info
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