Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Phytonadione Injectable Emulsion USP Recalled by Dr. Reddy's Laboratories, Inc. Due to Failed Stability Specifications: Out of specification results reported...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Dr. Reddy's Laboratories, Inc. directly.
Affected Products
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
Quantity: 2,838 ampules
Why Was This Recalled?
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Laboratories, Inc. has 163 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report