Why it was recalled
Failed Stability Specifications: Observed OOS results: eg results for colour index
Product description
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
Lot numbers, UPCs & expiration codes
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0197-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 31, 2025
- FDA report date
- Dec 10, 2025
- Quantity
- 4,438 10x1mL cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cipla Limited
Original FDA data
Every field from FDA enforcement report D-0197-2026, exactly as published.
Show all FDA fields
- City
- Pithampur, District Dhar
- Status
- Ongoing
- Country
- India
- Event ID
- 97909
- Address
- Plot No. 9 & 10, Pharma Zone Phase Ii
- Address (line 2)
- Section Iiii, Indore Special Economic Zone
- Code information
- Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
- Report date
- Dec 10, 2025
- Product type
- Drugs
- Recall number
- D-0197-2026
- Classification
- Class II
- Recalling firm
- Cipla Limited
- Product quantity
- 4,438 10x1mL cartons
- Reason for recall
- Failed Stability Specifications: Observed OOS results: eg results for colour index
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Oct 31, 2025
- Center classification date
- Nov 28, 2025