Octreotide Acetate for Injectable Suspension — Class II drug recall D-0404-2026
Ongoing recall by Teva Pharmaceuticals USA, Inc, reported 2026-04-01, distributed nationwide. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Admi
| Recall number | D-0404-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2026-03-17 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,897 cartons |
| Reason classes | sterility |
| NDC | 00480-9256-01, 00480-9257, 00480-9257-08, 00480-9258-01, 00480-9259, 00480-9259-08, 00480-9260-01, 00480-9262, 00480-9262-08, 00480-9263-21 |
| Lot numbers | 4401619, 4501005 |
| Expiration dates | 2026-09-30 |
Product
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.
Reason for recall
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0404-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.