RecallReported September 30, 2026
Class II recall by Amneal Pharmaceuticals of New York, LLC
Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by…
FDA's enforcement report of September 30, 2026 lists a Class II recall by Amneal Pharmaceuticals of New York, LLC of Brookhaven, NY. Product: Exenatide Injection, USP, 250 mcg/mL, 1.2 mL per prefilled pen, Rx Only, Subcutaneous Use Only, For Single Patient Use Only, Manufactured by…. Status: Ongoing.
On the record
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Location
- Brookhaven, NY
- Classification
- Class II
- Status
- Ongoing
- Recall number
- D-0868-2026
- Product type
- Drugs
- Brand names
- EXENATIDE
- Generic names
- EXENATIDE
- Recall initiated
- 2026-08-28
- Reported by FDA
- 2026-09-30
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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