Octreotide Acetate 20mg Class II Sterility Recall

FDA: Drug Recalls Class II

Filed April 1st, 2026

Detected April 7th, 2026

Summary

FDA classified a Class II recall for Teva Pharmaceuticals USA's Octreotide Acetate 20mg injectable suspension (NDC 0071-4185-25) due to lack of sterility assurance. The recall stems from quality system deficiencies identified at the contract manufacturer Pharmathen International S.A. in Greece during a routine FDA inspection. The affected product was distributed nationwide in the USA.

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What changed

Teva Pharmaceuticals USA is recalling Octreotide Acetate for Injectable Suspension 20mg single-dose vials (8mL) manufactured by Pharmathen International S.A. in Rodopi, Greece. FDA determined the recall is Class II due to lack of sterility assurance, citing quality system deficiencies discovered during a routine FDA inspection at the contract manufacturing facility. The recall number is D-0405-2026 and is currently ongoing.

Healthcare providers should immediately check their inventory for affected product and quarantine any remaining stock. Pharmacies and distributors must stop distributing the affected lots and coordinate with Teva for return procedures. Patients who have received this medication should contact their healthcare provider to discuss potential alternatives, though no adverse events have been reported at this time. The recall applies to all nationwide US distribution.

What to do next

Quarantine and discontinue use of Octreotide Acetate 20mg vials from affected lots
Report any adverse events potentially associated with use of this product to FDA MedWatch
Coordinate with Teva Pharmaceuticals to return affected product and notify patients as appropriate

Source document (simplified)

Teva Pharmaceuticals USA, Inc

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0405-2026 · 20260401 · Ongoing

Product

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 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.