# FDA recall D-0404-2026

> **Teva Pharmaceuticals USA, Inc** · Class II · drug recall initiated 2026-03-17.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0404-2026
- **Recalling firm:** Teva Pharmaceuticals USA, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-17
- **Report date:** 2026-04-01

- **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-0404-2026

## Citation

> AI Analytics. FDA recall D-0404-2026. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0404-2026. Source: US FDA. Licensed CC0.

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