Cipla Limited recalls Phytonadione Injectable Emulsion
- Recalling company
- Cipla Limited
- 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
- Failed Stability Specifications: Observed OOS results: eg results for colour index
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 31, 2025
- Reported
- Dec 10, 2025
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 4,438 10x1mL cartons
- Lot / codes
- Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
- Company location
- Pithampur, District Dhar
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0197-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0197-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.