Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol recall
FDA recall D-0560-2025 · initiated Jul 18, 2025
AEQUITA PHARMACY recalled Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol in Jul 2025 — an FDA Class II recall (D-0560-2025) because Lack of Processing Controls.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Processing Controls.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 155 vials
Details
- Product
- Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 3 x 2 mL Multi Dose Vial, Refrigerate, Do not freeze, Aequita Pharmacy LLC, Kirkland, WA 98034.
- Recalling company
- AEQUITA PHARMACY
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- MA
- Initiated
- Jul 18, 2025
- FDA report date
- Aug 13, 2025
Frequently asked
- Was Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol recalled?
- AEQUITA PHARMACY recalled Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol in Jul 2025 — an FDA Class II recall (D-0560-2025) because Lack of Processing Controls. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol recalled?
- Per the FDA enforcement record, the reason for recall D-0560-2025 was: Lack of Processing Controls.
- Is a recalled Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol are affected?
- Distributed: MA. The recall covers these lots — All Lots within expiry.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0560-2025.