Aequita Pharmacy Recalls Tirzepatide + Niacinamide Injections Due to Manufacturing Control Issues
Aequita Pharmacy is recalling Tirzepatide + Niacinamide injection solution due to lack of manufacturing process controls. Anyone currently using this medication should contact their healthcare provider.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard (inadequate manufacturing controls) is theoretical and undocumented, meeting the threshold for Moderate severity per the rubric.
Plain-English summary
Aequita Pharmacy LLC is recalling Tirzepatide + Niacinamide injectable solution (6.6 mg + 1.0 mg/0.5 mL) in 2 mL multi-dose vials. The recall affects 160 vials of this sterile injectable product.
The recall was issued due to lack of processing controls during manufacturing. The FDA classified this as a Class II recall. No illnesses or injuries have been reported.
Patients who are currently using this medication should contact their healthcare provider to discuss the recall and to explore alternative treatment options. Do not discontinue use without medical guidance.
The recalled product
- Product
- Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
- Manufacturer
- AEQUITA PHARMACY
- Category
- Drug — Injectable medication
- Hazard
- manufacturing-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots within expiry.
Distribution
Distributed in 1 state:
- MA
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