Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, N
Summary
The FDA issued a Class II for Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Val by New Life Pharma LLC. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0395-2026
Action Date
2026-03-11
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot 240709, exp 7/31/2026
Quantity Affected: 45 vials
Reason for Recall
Lack of Assurance of Sterility
Distribution
OH
Type: Voluntary: Firm initiated
Recall Initiated: 2026-02-26
Company
Northvale, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 85 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
New Life Pharma LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (New Life Pharma LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does New Life Pharma LLC have FDA actions?
New Life Pharma LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0395-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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