Cipla Limited: Drug Recall
Recall #D-0197-2026 · 10/31/2025
Class II: Risk
Recall Details
- Recall Number
- D-0197-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Cipla Limited
- Status
- Ongoing
- Date Initiated
- 10/31/2025
- Location
- Pithampur, District Dhar, India
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,438 10x1mL cartons
Reason for Recall
Failed Stability Specifications: Observed OOS results: eg results for colour index
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
Distribution Pattern
Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.