Quick Facts at a Glance
- Recall Date
- October 31, 2025
- Hazard Level
- HIGH
- Brands
- PHYTONADIONE, Cipla USA Inc.
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- PHYTONADIONE, Cipla USA Inc.
- Product type
- Injectable Emulsion
- Model numbers
- Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
- UPC codes
- 69097-708, 69097-709, 69097-709-96, 69097-708-96, 69097-708-31
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 31, 2025
Reported by FDA DRUG
December 10, 2025
RecallRadar source check
December 17, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Stability Specifications: Observed OOS results: eg results for colour index
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Cipla Limited or your healthcare provider for guidance
About This Product
Phytonadione Injectable Emulsion is a medication used to treat vitamin K deficiency and support patients on anticoagulants. It is typically administered in clinical settings.
Why This Is Dangerous
The product's failure in stability specifications means it may not perform as intended, potentially leading to ineffective treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers must cease use of the product immediately to avoid health risks. The recall could lead to disruption in treatment for individuals relying on vitamin K supplementation.
Practical Guidance
How to identify if yours is affected
- Locate the batch number on the vial or carton.
- Check if it matches Batch # PH0072404A or PH0082404A.
- Ensure the expiration date is December 31, 2025.
Where to find product info
Batch numbers and expiration dates can be found on the vial label or carton packaging.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document your correspondence with the company.
- Reach out to the FDA if you do not receive a response.
- Consider contacting a consumer protection agency if issues persist.
How to prevent similar issues
- Always check for recalls on medications before use.
- Consult healthcare providers regarding any concerns with medications.
- Be aware of stability specifications when using injectable products.
Documentation advice
Keep records of your purchase, including receipts and any communications with the manufacturer or retailer.
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Product Details
This recall involves Phytonadione Injectable Emulsion, USP 10mg/mL, in 10x1 mL single-dose vials. The vials have NDC# 69097-708-31, and the cartons have NDC 69097-708-96. This product was manufactured by Cipla Ltd. in India for Cipla USA, Inc. and has a lot number PH0072404A.
Key Facts
- Recall date: October 31, 2025
- Quantity recalled: 4,438 cartons
- Manufactured in India
- Rx only product
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Safety Guide
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