Tirzepatide + Niacinamide 8 — Class II drug recall D-0557-2025
Ongoing recall by AEQUITA PHARMACY, reported 2025-08-13, distributed in MA. Lack of Processing Controls.
| Recall number | D-0557-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AEQUITA PHARMACY, Kirkland, WA, United States |
| Recall initiated | 2025-07-18 |
| Classified | 2025-08-01 |
| Reported by FDA | 2025-08-13 |
| Distributed | MA |
| Quantity | 139 vials |
Product
Tirzepatide + Niacinamide 8.8 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.
Reason for recall
Lack of Processing Controls.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0557-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.