Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Lisdexamfetamine Dimesylate Capsules Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to Failed Dissolution Specifications: An out of specification results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SUN PHARMACEUTICAL INDUSTRIES INC directly.
Affected Products
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
Quantity: 5,448 bottles
Why Was This 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).
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SUN PHARMACEUTICAL INDUSTRIES INC
SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report