FDA Drug recall D-0395-2026
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04
- FDA Drug
- Class II
- ongoing
- Published 2026-03-11
On 2026-03-11 the FDA classified a Class II recall of Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04 by New Life Pharma, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0395-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-26 |
| Published | 2026-03-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | New Life Pharma |
| Distribution | OH |
Product
Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot 240709, exp 7/31/2026 |
|---|
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-0395-2026%22
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