Amneal recalls exenatide pens for empty-pen defect; also logs four labeling approvals

Amneal Pharmaceuticals' biggest item of the week is a product recall, with four routine labeling updates rounding out the record.

• Amneal Pharmaceuticals of New York initiated a Class II recall of Exenatide Injection, USP, 250 mcg/mL prefilled pens, with the reason given as a defective delivery system with the possibility of no medication in the prefilled pen.¹ The recall covers 5,694 pens from lot AP250095A, expiring 2/28/2027, distributed nationwide¹, and was voluntarily initiated by the firm¹; as of the report date the action is listed as ongoing, with initiation on 20260828 and FDA center classification dated 20260922.¹
• FDA approved labeling supplement number 8 for Amneal's lacosamide tablets under ANDA204857, covering 50MG, 100MG, 150MG, and 200MG oral strengths, with a submission status date of 2026-09-29.²
• A second labeling supplement, number 9, for the same lacosamide tablet application was also approved, with a submission status date of 2026-09-29.^3,4
• A third labeling supplement, number 4, for the same lacosamide tablet ANDA was approved as well, with a submission status date of 2026-09-29.
• FDA approved labeling supplement number 5 for Amneal's labetalol hydrochloride injectable under ANDA218870, 5MG/ML strength, with a submission status date of 2026-09-28.⁵