FDAClass IIAugust 13, 2025

Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj recall

Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial…

Why was Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj recalled?

Lack of Processing Controls.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots within expiry.

Product
Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial…
Recalling firm
AEQUITA PHARMACY
Quantity
146 vials
Distribution
MA
Recall date
August 13, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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