Class II · Moderate risk
Kinevac (Sincalide for Injection)
cGMP deviations: Temperature abuse
Is Sincalide recalled?
Not under an active recall.
Sincalide was recalled 4 times in the past — all now closed. Most recent: Apr 13, 2022.
Most common reason: cGMP deviation (1 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sincalide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Sincalide recalls on record
none so far in 2026; 4 on record, newest first
Class II · Moderate risk
Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Class II · Moderate risk
Sincalide 5 mcg Lyophilized Vials
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
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