CLASS II ONGOING Drug recall · Reported 10 Dec 2025 · FDA Enforcement Report
Phytonadione Injectable Emulsion, USP 10mg/mL recalled by Cipla
Cipla is recalling Phytonadione Injectable Emulsion, USP 10mg/mL, mL Single-Dose Vial/carton, distributed nationwide in the US. The recall was initiated on 31 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0197-2026
- FDA event ID
- 97909
- Recalling firm
- Cipla, Pithampur, District Dhar
- Brand
- Phytonadione
- Manufacturer
- Cipla USA Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Oct 2025
- FDA classified
- 28 Nov 2025
- Reported
- 10 Dec 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 31 Oct 2025 | Recall initiated by company | |
| 28 Nov 2025 | Classified by FDA | +28 days |
| 10 Dec 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Observed OOS results: eg results for colour index
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Observed OOS results: eg results for colour index
Which lots are affected?
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Drug | CLASS II | Difluprednate Ophthalmic Emulsion recalled by CIPLADifluprednate | Cipla | Sterility | Nationwide |
Other Phytonadione recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Phytonadione Injectable Emulsion USP, 10 mg/mL recalledPhytonadione | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Phytonadione Tablets, 5 mg ablets recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS III | Phytonadione Tablets 5 mg recalled by AVKARE | Avkare | Potency & Assay | CA |
| Drug | CLASS III | Phytonadione Tablets 5mg recalled by Bausch Health Companies | Bausch Health Companies | Potency & Assay | Nationwide |
| Drug | CLASS I | Phytonadione Injectable Emulsion, USP, 10 mg/mL ampule recalledPhytonadione | Dr. Reddy's Laboratories | Packaging Defects | Nationwide |