Phytonadione Injectable Emulsion — Class II drug recall D-0197-2026
Ongoing recall by Cipla Limited, reported 2025-12-10, distributed nationwide. Failed Stability Specifications: Observed OOS results: eg results for colour index
| Recall number | D-0197-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cipla Limited, Pithampur, District Dhar, India |
| Recall initiated | 2025-10-31 |
| Classified | 2025-11-28 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 4,438 |
| Reason classes | specification failure |
| NDC | 69097-0708, 69097-0708-31, 69097-0708-96, 69097-0709, 69097-0709-96 |
| Lot numbers | PH0072404A, PH0082404A |
| Expiration dates | 2025-12-31 |
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 for recall
Failed Stability Specifications: Observed OOS results: eg results for colour index
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0197-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.