Phytonadione Recall: Cipla Injectable Emulsion
Announced 2026-07-08 · FDA
FDA is recalling Phytonadione Injectable Emulsion, USP 10 mg/mL, 10x1 mL single-dose vials (Rx Only) distributed nationwide in the USA. The recall is due to failed stability specifications with out-of-spec results for color index. About 4,438 cartons are affected (Batch PH0072404A, PH0082404A; Exp. 12/31/2025); Vial NDC 69097-708-31; Carton NDC 69097-708-96.
| Brand | Cipla Limited |
|---|---|
| Product | Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96 |
| Reason | Failed Stability Specifications: Observed OOS results: eg results for colour index |
| Severity | moderate |
| Units affected | 31824 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025 |
WHAT YOU SHOULD DO
- Do not use recalled Phytonadione Injectable Emulsion from the affected batches.
- If you have the product, contact your healthcare provider or pharmacist for guidance and potential replacement.
- Return or dispose of the recalled product according to recall instructions or local regulations.
- Monitor for updates from the FDA and Cipla USA.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.