Dr. Reddy's Phytonadione Injectable Emulsion Recall: Stability Failure Risk
Dr. Reddy's recalls 10 mg/mL Phytonadione Injectable Emulsion due to stability issues at 12-month testing. This may affect medication safety. Check NDC 43598-405-16 and lot numbers for affected products.
Lower-risk recall
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Contact the company
What happened, in plain English
Dr. Reddy's is recalling a vitamin K injection product because stability tests showed aluminum content was out of specification after 12 months. This could mean the medication might not be safe for use after the expiration date. Read more at govinfonow.com/recall/34327-dr-reddy-s-phytonadione-injectable-emulsion-recall-stability-failure-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34327-dr-reddy-s-phytonadione-injectable-emulsion-recall-stability-failure-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0007-2023
Cite this page
“Dr. Reddy's Phytonadione Injectable Emulsion Recall: Stability Failure Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34327-dr-reddy-s-phytonadione-injectable-emulsion-recall-stability-failure-risk. Based on FDA recall #D-0007-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0007-2023%22&limit=1).
Why it’s dangerous
The product failed stability testing at 12 months, showing aluminum content was outside acceptable limits. This could potentially affect the medication's safety and effectiveness over time.
Who’s affected
Prescription patients using the recalled vitamin K injection. Healthcare providers who dispense this medication are most at risk.
How to tell if you have this one
Check for NDC code 43598-405-16 and lot number ACB101 on the product packaging. The product is a prescription-only vitamin K injection sold in 25 single-dose vials per carton.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 43598-405-16 and lot number ACB101 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 28 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0007-2023 (September 14, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0007-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.