FDA Drug recall D-0197-2026
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd
- FDA Drug
- Class II
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class II recall of Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd by Cipla, citing failed Stability Specifications: Observed OOS results: eg results for colour index.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0197-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-10-31 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Cipla |
| Distribution | US |
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
Identifiers
| ndc | 69097-709-96 |
|---|---|
| ndc | 69097-708-96 |
| ndc | 69097-708-31 |
| code_info | Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0197-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.