D-0404-2026 Class II Ongoing
FDA drug recall D-0404-2026 was initiated by Teva Pharmaceuticals USA, Inc on Mar 17, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1,897 Cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 1, 2026
- Initiation Date
- Mar 17, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,897 Cartons
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0404-2026
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026