Teva octreotide acetate 20 mg recalled over sterility assurance deficiencies
Teva is recalling nine lots of Octreotide Acetate for Injectable Suspension 20 mg after quality system deficiencies were identified during an FDA inspection at the contract manufacturer.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: this is an FDA Class II recall of an injectable medicine whose sterility cannot be assured, with no injuries stated.
Plain-English summary
Teva Pharmaceuticals USA, Inc is recalling Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, in single-dose 8 mL vial kits, prescription only, manufactured in Greece by Pharmathen International S.A., NDC 0480-9259-08. About 19,869 cartons were distributed nationwide in the United States. The FDA has classified this recall as Class II.
The recall was initiated for lack of assurance of sterility, following quality system deficiencies identified during a routine FDA inspection at the contract manufacturer.
Affected product covers lots 4401491, 4401600, 4401603 and 4401629 (expiry September 2026), and lots 4500594, 4500786, 4500920, 4501007 and 4501462 (expiry 3/31/2027).
Patients and pharmacies can identify affected product by the NDC and lot numbers above, and may contact Teva Pharmaceuticals USA, Inc for further information.
The recalled product
- Product
- OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
- Brand
- OCTREOTIDE ACETATE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Injectable
- Affected units
- 19,869
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot: 4401491
- 4401600
- 4401603
- 4401629
- Exp.: 9/31/2026
- 4500594
- 4500786
- 4500920
- 4501007
- 4501462
- Exp.: 3/31/2027.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Teva Pharmaceuticals USA, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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