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Priority review Enforcement Added Final

Teva Pharmaceuticals Octreotide Acetate Class II Sterility Recall

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Filed April 1st, 2026
Detected April 7th, 2026
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Summary

The FDA announced a Class II recall of Teva Pharmaceuticals' Octreotide Acetate for Injectable Suspension 10mg single-dose vials due to lack of sterility assurance. Quality system deficiencies were identified at the contract manufacturer Pharmathen International S.A. in Greece during a routine FDA inspection. The recall affects products distributed nationwide in the USA and is currently ongoing.

What changed

Teva Pharmaceuticals USA initiated a voluntary Class II recall for Octreotide Acetate for Injectable Suspension 10mg (single-dose 8mL vials) distributed nationwide. The recall was triggered by quality system deficiencies identified at the contract manufacturer Pharmathen International S.A. in Greece during a routine FDA inspection, raising concerns about sterility assurance of the product.\n\nHealthcare providers and distributors should immediately identify and quarantine any affected product in their inventory and cease administration. Pharmacies and healthcare facilities should notify patients who may have received this medication. The recall is ongoing and no specific return deadline was provided. Adverse reactions or quality problems should be reported to the FDA MedWatch program.

What to do next

  1. Identify and quarantine all Octreotide Acetate 10mg vials from affected lots in inventory
  2. Cease administration of recalled product and notify affected patients
  3. Report any adverse events or quality issues to FDA MedWatch

Source document (simplified)

Teva Pharmaceuticals USA, Inc

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0404-2026 · 20260401 · Ongoing

Product

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, M...

Reason for Recall

Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

Distribution

Nationwide in the USA

Source: openFDA Enforcement API

Source

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

Classification

Agency
FDA
Filed
April 1st, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
Class II D-0404-2026

Who this affects

Applies to
Pharmaceutical companies Healthcare providers
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug Manufacturing Drug Distribution
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Compliance
Compliance frameworks
GxP
Topics
Product Safety Healthcare

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