FDA recall, , Moderate risk
Teva Octreotide Acetate for Injectable Suspension
Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies.
Summary by Recall Canary from the FDA notice
What happened
Teva Pharmaceuticals USA, Inc. recalled Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, in single-dose kits, because of a lack of assurance of sterility due to quality system deficiencies identified during a routine U.S. Food and Drug Administration inspection at the contract manufacturer. The recall began April 24, 2026, and was added to the FDA's Enforcement Report on May 5, 2026.
The product was manufactured in Greece by Pharmathen International S.A. and distributed nationwide in the USA. The kits contain an 8-mL vial of 30 mg strength, a pre-filled syringe with 2 mL of diluent, one vial adapter, and one sterile 1 19-gauge safety injection needle, for Rx only.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC or UPC is listed.
A UPC is the number printed under a barcode. An NDC (National Drug Code) is usually printed on the drug's label.
Octreotide Acetate for Injectable Suspension
- NDC
- 0480-9262-08
- 0480-9260-01
- 0480-9263-21
- UPC
- 45011002
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- Teva Pharmaceuticals USA, IncParsippany, New Jersey
- Hazard
- Sterility problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98810
- Recall number
- D-0519-2026
- Quantity recalled
- 2,200 kits
All recalls from Teva Pharmaceuticals USA, Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
