# FDA recall D-0519-2026

> **Teva Pharmaceuticals USA, Inc** · Class II · drug recall initiated 2026-04-24.

## Product

Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿  19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.

## 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

Nationwide in the USA

## Key facts

- **Recall number:** D-0519-2026
- **Recalling firm:** Teva Pharmaceuticals USA, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-04-24
- **Report date:** 2026-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0519-2026

## Citation

> AI Analytics. FDA recall D-0519-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0519-2026. Source: US FDA. Licensed CC0.

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