October 2025 FDA Recall Phytonadione by Cipla Limited
D-0197-2026 - Failed Stability Specifications
This Class II drug recall was voluntarily initiated by Cipla Limited on October 31, 2025 for the product Phytonadione. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0197-2026
Failed Stability Specifications: Observed OOS results: eg results for colour index
10-31-2025
12-10-2025
4,438 10x1mL cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Cipla Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Batch# PH0072404A, PH0082404A, Exp. Date December 31, 2025
