FDA Drug recall D-0555-2025
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial,…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class II recall of Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2 mL Multi Dose Vial,… by Aequita Pharmacy, citing lack of Processing Controls.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0555-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-18 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aequita Pharmacy |
| Distribution | MA |
Product
Tirzepatide + Niacinamide 4.4 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
Lack of Processing Controls.
Identifiers
| code_info | All Lots within expiry. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0555-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.