SUN PHARMACEUTICAL INDUSTRIES INC 2025-11-05 Health serious FDA
Health · FDA · Recall #FDA-D-0148-2026
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured… Recall
Issued November 5, 2025 · SUN PHARMACEUTICAL INDUSTRIES INC
In November 2025, SUN PHARMACEUTICAL INDUSTRIES INC recalled the Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact SUN PHARMACEUTICAL INDUSTRIES INC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Health
- Recall date
- November 5, 2025
- Units affected
- Not reported
- Sold at
- U.S Nationwide.
- Recall number
- FDA-D-0148-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- SUN PHARMACEUTICAL INDUSTRIES INC has 34 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.