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Class II · ModerateActive recall

Lisdexamfetamine Dimesylate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # AD42648, Exp 02/28/2026
Where it was soldRecalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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).

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byOHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ 08512
Brand nameLISDEXAMFETAMINE DIMESYLATE
Generic nameLISDEXAMFETAMINE DIMESYLATE
Active ingredient(s)LISDEXAMFETAMINE DIMESYLATE
Distributed by / forSun Pharmaceuticals, Inc., Cranbury, NJ 08512
NDC57664-051-88
Show the full FDA record
Full product labelLisdexamfetamine 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
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionRecalled units were distributed to 17 distributors who may have further distributed the product nationwide.
Quantity5,448 bottles
Recall initiated2025-06-16
Report date2025-07-23
Recall completed—
Recall numberD-0516-2025
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.