FDAClass IIMay 13, 2026

Octreotide Acetate for Injectable Suspension recall: Sterility Concern

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a…

Why was Octreotide Acetate for Injectable Suspension recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: 45011002, Exp. 03/31/2027

Product
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a…
Recalling firm
Teva Pharmaceuticals USA, Inc
Quantity
2,200 kits
Distribution
Nationwide in the USA
Recall date
May 13, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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