Home / Recalls / Cipla Limited / D-0197-2026

D-0197-2026 Class II Ongoing

Recalled by Cipla Limited — Pithampur, District Dhar

FDA drug recall D-0197-2026 was initiated by Cipla Limited on Oct 31, 2025 and is designated Class II. Reason for recall: Failed Stability Specifications: Observed OOS results: eg results for colour index The recall status is ongoing. Affected quantity: 4,438 10x1mL cartons.

Recall Details

Product Type: Drugs
Report Date: Dec 10, 2025
Initiation Date: Oct 31, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,438 10x1mL cartons

Product Description

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 Pattern

Nationwide in the USA

Code Information

Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0197-2026
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.