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New Life Pharma LLC Class II Drug Recall - Semaglutide Inj

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Filed March 11th, 2026
Detected March 28th, 2026
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Summary

The FDA has issued a Class II drug recall for Semaglutide Inj manufactured by New Life Pharma LLC due to a lack of assurance of sterility. The recall affects product distributed in Ohio.

What changed

The Food and Drug Administration (FDA) has initiated a Class II drug recall for Semaglutide Inj (NDC 84223-001-07) manufactured by New Life Pharma LLC. The recall is due to a lack of assurance of sterility and impacts product distributed in Ohio.

This recall signifies a critical product quality issue that requires immediate attention from any entities involved in the distribution or handling of this specific Semaglutide Inj product. While the document does not specify a compliance deadline, the nature of a sterility issue necessitates prompt action to remove the product from circulation to prevent potential patient harm. Companies should review their inventory and distribution records for affected lots and coordinate with New Life Pharma and the FDA regarding disposition and reporting.

What to do next

  1. Review inventory and distribution records for affected Semaglutide Inj lots.
  2. Cease distribution of recalled product.
  3. Coordinate with New Life Pharma and the FDA on product disposition and reporting.

Source document (simplified)

New Life Pharma LLC

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0392-2026 · 20260311 · Ongoing

Product

Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.

Reason for Recall

Lack of Assurance of Sterility

Distribution

OH

Source: openFDA Enforcement API

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
FDA
Filed
March 11th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0392-2026

Who this affects

Applies to
Drug manufacturers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Recalls Drug Manufacturing
Threshold
Class II drug recall
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
FDA 21 CFR Part 11 GxP
Topics
Product Safety Drug Manufacturing

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