Phytonadione Injectable Emulsion recall
FDA recall D-0197-2026 · initiated Oct 31, 2025
Cipla Limited recalled Phytonadione Injectable Emulsion in Oct 2025 — an FDA Class II recall (D-0197-2026) because Failed Stability Specifications: Observed OOS results: eg results for colour index.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Stability Specifications: Observed OOS results: eg results for colour index
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,438 10x1mL cartons
Details
- 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
- Recalling company
- Cipla Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Oct 31, 2025
- FDA report date
- Dec 10, 2025
Frequently asked
- Was Phytonadione Injectable Emulsion recalled?
- Cipla Limited recalled Phytonadione Injectable Emulsion in Oct 2025 — an FDA Class II recall (D-0197-2026) because Failed Stability Specifications: Observed OOS results: eg results for colour index. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Phytonadione Injectable Emulsion recalled?
- Per the FDA enforcement record, the reason for recall D-0197-2026 was: Failed Stability Specifications: Observed OOS results: eg results for colour index
- Is a recalled Phytonadione Injectable Emulsion dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Phytonadione Injectable Emulsion are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0197-2026.