Reported Jul 23, 2025 · Ongoing
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only
- Manufactured byOHM Laboratories, New Brunswick, NJ 08901
- Distributed bySun Pharmaceuticals, Inc., Cranbury, NJ 08512, NDC 57664-051-88
- Lot codes and dates
Lot # AD42648Exp 02/28/2026
- Amount recalled
- 5,448 bottles
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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