# FDA recall D-0197-2026

> **Cipla Limited** · Class II · drug recall initiated 2025-10-31.

## Product

Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96

## Reason for recall

Failed Stability Specifications: Observed OOS results: eg results for colour index

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0197-2026
- **Recalling firm:** Cipla Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-31
- **Report date:** 2025-12-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pithampur, District Dhar, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0197-2026

## Citation

> AI Analytics. FDA recall D-0197-2026. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/D-0197-2026. Source: US FDA. Licensed CC0.

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