FDA Recall D-0197-2026

Cipla Limited

Class II Ongoing 195 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025

Quantity: 4,438 10x1mL cartons

Reason for recall

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

Recall record

Recall number: D-0197-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Distribution: Nationwide in the USA
Recall initiated: 2025-10-31
Classified by FDA Center: 2025-11-28
FDA published: 2025-12-10
Recalling firm: Cipla Limited

Drug identification

Brand name(s): PHYTONADIONE
Generic name(s): PHYTONADIONE
Manufacturer(s): Cipla USA Inc.
NDC(s): 69097-708, 69097-709
Route(s): INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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