FDA recall, , Moderate risk
Sun Pharmaceutical Lisdexamfetamine Dimesylate Capsules
Lisdexamfetamine Dimesylate Capsules 40 mg may not dissolve properly in the body.
Summary by Recall Canary from the FDA notice
What happened
Sun Pharmaceutical Industries Inc. of Princeton, New Jersey, is voluntarily recalling Lisdexamfetamine Dimesylate Capsules 40 mg, 100-count bottles, because the product failed dissolution specifications, according to the FDA. The recall was initiated by the firm on October 21, 2026, and added to the FDA's Enforcement Report on November 6, 2026.
The product is distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, and manufactured by Ohm Laboratories, New Brunswick, NJ 08901. The recall involves 17,760 bottles and customers were notified by letter.
The affected capsules were distributed in Mississippi and Ohio.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Lisdexamfetamine Dimesylate Capsules 40 mg
- NDC
- 57664-049-88
- Lot code
- AD97036
- AE05842
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
- Recalled by
- SUN PHARMACEUTICAL INDUSTRIES INCPrinceton, New Jersey
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100165
- Recall number
- D-0174-2027
- Quantity recalled
- 17,760 bottles
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from SUN PHARMACEUTICAL INDUSTRIES INC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
SUN PHARMACEUTICAL INDUSTRIES INC began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
