CLASS III Drug recall · Reported 12 Oct 2022 · FDA Enforcement Report
Phytonadione Injectable Emulsion USP, 10 mg/mL recalled
Dr. Reddy's Laboratories is recalling Phytonadione Injectable Emulsion USP, 10 mg/mL, mL single dose ampules per, distributed nationwide in the US. The recall was initiated on 14 Sep 2022 and the FDA has classified it as Class III.
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-0007-2023
- FDA event ID
- 90868
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Phytonadione
- Manufacturer
- Dr.Reddy's Laboratories Inc
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 14 Sep 2022
- FDA classified
- 6 Oct 2022
- Reported
- 12 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 14 Sep 2022 | Recall initiated by company | |
| 6 Oct 2022 | Classified by FDA | +22 days |
| 12 Oct 2022 | Published in enforcement report | +6 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: Out of specification results reported at 12-month stability testing for aluminum content.
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, 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
Where it was distributed
USA nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Which lots are affected?
Lot # ACB101, Exp 03/2023
Where was it sold?
USA nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Phytonadione recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phytonadione Injectable Emulsion, USP 10mg/mL recalled by CiplaPhytonadione | Cipla | 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 |