HIGH

Teva Octreotide Acetate Injectable Suspension Recall 19,869 Cartons Nationwide (2026)

Teva Pharmaceuticals USA recalled 19,869 cartons of Octreotide Acetate for Injectable Suspension nationwide in the United States after FDA inspection flagged lack of assurance of sterility at the contract manufacturer. The FDA cited quality system deficiencies at Pharmathen International S.A. in Greece. Healthcare providers and patients should stop using the product immediately and contact Teva or

Quick Facts at a Glance

Recall Date
March 17, 2026
Hazard Level
HIGH
Brands
OCTREOTIDE ACETATE, Teva Pharmaceuticals, Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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 You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter

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Product Details

Product: Octreotide Acetate for Injectable Suspension Strength/Volume: 20 mg, 8 mL single-dose vial Form: Injectable suspension Rx: Yes (Rx only) NDC: 0480-9259-08 Manufactured in: Pharmathen International S.A., Rodopi, 693 00 Greece Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054 Quantity: 19,869 cartons Distribution: Nationwide in the USA Lot/Exp: Lot 4401491, 4401600, 4401603, 4401629; Exp. 9/31/2026 Lot: 4500594, 4500786, 4500920, 4501007, 4501462; Exp. 3/31/2027

The Hazard

Lack of Assurance of Sterility due to quality system deficiencies identified during an FDA inspection at the contract manufacturer.

Reported Incidents

No injuries or incidents have been reported.

What to Do

1. Stop using the product. 2. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. 3. You will receive a recall notification by letter.

Contact Information

Phone: Unknown Website: https://www.tevausa.com Hours: Unknown

Key Facts

  • Cartons recalled: 19,869
  • NDC: 0480-9259-08
  • Lot numbers: 4401491, 4401600, 4401603, 4401629, 4500594, 4500786, 4500920, 4501007, 4501462
  • Expiration dates: 9/31/2026 and 3/31/2027
  • Manufactured for Teva Pharmaceuticals USA, Inc.
  • Manufactured in Greece by Pharmathen International S.A.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lot: 4401491
4401600
4401603
4401629
Exp.: 9/31/2026
+6 more
UPC Codes
0480-9257
0480-9259
0480-9262
+7 more
Affected States
ALL
Report Date
April 1, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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