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Drug FDA Class II Ongoing Failed specifications

Lisdexamfetamine Dimesylate Capsules, 70 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 57664-052-88.

SUN PHARMACEUTICAL INDUSTRIES INC Published Nov 5, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact SUN PHARMACEUTICAL INDUSTRIES INC or your place of purchase with questions, and see the source record below for full details.
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.

Hazards

Failed Dissolution · primary

Affected products (1)

Lisdexamfetamine Dimesylate Capsules, 70 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 57664-052-88.

LISDEXAMFETAMINE DIMESYLATE · N/A

NDC: 57664-046, 57664-047, 57664-048, 57664-049, 57664-050, 57664-051, 57664-052, 57664-083, 57664-084, 57664-085, 57664-086, 57664-087, 57664-088, 57664-047-88, 57664-046-88, 57664-048-88, 57664-049-88, 57664-050-88, 57664-051-88, 57664-052-88, 57664-083-88, 57664-084-88, 57664-085-88, 57664-086-88, 57664-087-88, 57664-088-88
Code info: Lot #: AD48712, Expiry: 4/30/2026; AD50898, Expiry: 5/31/2026.

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 28, 2025
  2. Published
    Nov 5, 2025
Recall number
D-0150-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.