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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 #:AD48710, Expiry: 4/30/2026; AD50895, Expiry: 5/31/2026.
Where it was soldU.S 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 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

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 Pharmaceutical Industries, Inc., Cranbury, NJ 08512
Brand nameLISDEXAMFETAMINE DIMESYLATE
Generic nameLISDEXAMFETAMINE DIMESYLATE
Active ingredient(s)LISDEXAMFETAMINE DIMESYLATE
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
NDC57664-050-88
Show the full FDA record
Full product labelLisdexamfetamine 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, NJ 08512, NDC 57664-050-88.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionU.S Nationwide.
QuantityN/A
Recall initiated2025-10-28
Report date2025-11-05
Recall completed—
Recall numberD-0148-2026
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.