Recalls / Class II
Class IID-0405-2026
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, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9259-08.
- Brand name
- Octreotide Acetate
- Generic name
- Octreotide Acetate
- Route
- Intramuscular
- NDCs
- 0480-9257, 0480-9259, 0480-9262
- FDA application
- ANDA210317
- Affected lot / code info
- Lot: 4401491, 4401600, 4401603, 4401629, Exp.: 9/31/2026; 4500594, 4500786, 4500920, 4501007, 4501462, Exp.: 3/31/2027.
Why it was 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.
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Teva Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 19,869 Cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2026-03-17
- FDA classified
- 2026-03-27
- Posted by FDA
- 2026-04-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0405-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.