TIRZEPATIDE 20 mg/2mL — Class II drug recall D-0655-2024
Ongoing recall by ProRx LLC, reported 2024-09-11, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0655-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ProRx LLC, Exton, PA, United States |
| Recall initiated | 2024-08-22 |
| Classified | 2024-09-05 |
| Reported by FDA | 2024-09-11 |
| Distributed | Nationwide (US) |
| Quantity | 1,489 vials |
| Reason classes | sterility |
| NDC | 84139-0210-01 |
| Lot numbers | PRORX051424 |
| Expiration dates | 2024-11-13 |
Product
TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01
Reason for recall
Lack of Assurance of Sterility
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-0655-2024. 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.