Open Veils · Answer
Lisdexamfetamine mfg:SUN AR/AR
Sun Pharmaceutical's lisdexamfetamine line runs through Ohm Laboratories (FEI 184769029), covering at least thirteen NDC codes across multiple strengths. A voluntary recall initiated October 21, 2026 flagged 17,760 bottles of the 40 mg capsules — lot numbers AD97036 and AE05842 — for failed dissolution specifications, meaning active drug may not absorb properly. Distribution of affected units was limited to Ohio and Mississippi. The FDA logged the action in its Enforcement Report on November 6, 2026.
Evidence
- The dissolution-failure recall is the second such action on this product line in roughly a year.
- Dissolution failure in an extended-release amphetamine prodrug context is clinically significant: lisdexamfetamine must hydrolyze to d-amphetamine after absorption, so a capsule that does not dissolve on schedule delivers an unpredictable or absent therapeutic dose.
- Affected patients are advised to check lot numbers, return product to point of purchase, and consult a pharmacist or prescriber before discontinuing.
- FDA package insert records dated July 7, 2026 list thirteen separate manufacture operations assigned to Ohm under FEI 184769029.
- Republic Pharma reported a December 2025 recall covering multiple strengths (10 mg–40 mg, lot series AD42468–AD48709) with expirations running to mid-2026.