Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Is Tirzepatide recalled?
Yes — there is an active recall. 21 ongoing FDA recalls mention Tirzepatide (21 total). Check the affected lots below.
Most common reason: Sterility / contamination (12 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Tirzepatide. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Tirzepatide recalls in 2026
2 initiated in 2026, 21 in total — newest first
Class II · Moderate risk
Tirzepatide Inj
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide Injections
Lack of Assurance of Sterility
Class II · Moderate risk
TIRZEPATIDE 60 mg/3mL
Lack of Assurance of Sterility
Class II · Moderate risk
TIRZEPATIDE 20 mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide 2 mL
Lack of Assurance of Sterility
Class I · High risk
Tirzepatide 10 mg/0.5 mL Sterile Solution
Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate
Class II · Moderate risk
Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial
Sub-potent Drug
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