FDA Drugs recall ·
Phytonadione Injectable Emulsion, USP 10mg/mL… recall
- Recall number
- D-0197-2026
- Date
- (initiated October 31, 2025)
- Company / brand
- Cipla USA, Inc.
Plot No. 9 & 10, Pharma Zone Phase Ii, Pithampur, District Dhar, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4,438 10x1mL cartons
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Stability Specifications: Observed OOS results: eg results for colour index
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0197-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.