Use cautionDrug recall · FDA · Published March 16, 2020
Dr. Reddy's Phytonadione Injectable Emulsion Recall: Ampules May Shatter Upon Opening
Dr. Reddy's recalls 25-pack of Phytonadione Injectable Emulsion ampules that may shatter when opened, posing a risk of injury. This medication is prescription-only and distributed by Dr. Reddy's Laboratories.
“Dr. Reddy's Phytonadione Injectable Emulsion Recall: Ampules May Shatter Upon Opening.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37327-dr-reddy-s-phytonadione-injectable-emulsion-recall-ampules-may-shatter. Based on FDA recall #D-1094-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1094-2020%22&limit=1).
The FDA announced on March 16, 2020, that Dr. Reddy's Laboratories, Inc. voluntarily recalled Phytonadione Injectable Emulsion due to defective containers that break and shatter upon opening. The recall affects lots ACB902 through ACB905 distributed nationwide.
Packaging: 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16)
Lot codes: ACB902, ACB903, ACB904, ACB905
Expiration dates: 03/2021, 04/2021, 06/2021
Quantity: 10,943 cartons
The hazard
The recall is due to the breaking and shattering of ampules upon opening. The FDA classified this as a Class I recall.
Context
GovInfoNow's records show Dr. Reddy's Laboratories, Inc. has had 85 other recalls on record since April 9, 2012. Other recent recalls of similar products include Dr. Reddy's Varenicline Tablets Recall (Nov. 11, 2025), Dr. Reddy's Succinylcholine Chloride Injection Recall (Sept. 26, 2025), and Dr. Reddy's Omeprazole Capsules Recall (June 30, 2025). Other recent recalls of similar products include Cipla Phytonadione Injectable Emulsion Recall (Oct. 31, 2025), Novocol OraVerse Injection Recall (Oct. 31, 2025), and Mallinckrodt Acthar Gel 5mL Vial Recall (Aug. 6, 2026).
How to tell if you have this one
Check for the product name 'Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule' in 25-count packages. The lot numbers ACB902, ACB903, ACB904, or ACB905 with expiration dates up to June 2021 are affected.
Brand
Dr. Reddy's
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Ampule Condition
Inspect the ampules for signs of breaking or shattering before use.
Return to Distributor
Contact Dr. Reddy's Laboratories for a refund or replacement if you have the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1094-2020 (March 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1094-2020 to see it in context.
Plain-language summary written by qwen3:4b on October 5, 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.