# FDA recall D-0423-2026

> **Cipla USA, Inc.** · Class II · drug recall initiated 2026-03-13.

## Product

Lanreotide Injection, 120 mg/0.5 mL, Box contains 1 Pre-filled syringe, Single dose only, Rx Only, Manufactured by: Pharmathen International, S.A., Rodopi, Greece.  Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67

## Reason for recall

Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0423-2026
- **Recalling firm:** Cipla USA, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-03-13
- **Report date:** 2026-04-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0423-2026

## Citation

> AI Analytics. FDA recall D-0423-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0423-2026. Source: US FDA. Licensed CC0.

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