Severity
Moderate
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
Reported: December 10, 2025 Initiated: October 31, 2025 #D-0197-2026 4,438 10x1mL cartons units
Cipla Limited issued this FDA Drug recall on December 10, 2025. Classified as Moderate severity (Class II). Approximately 4,438 10x1mL cartons units are affected. The recall was issued because: Failed Stability Specifications: Observed OOS results: eg results for colour index. This recall notice is sourced from official FDA Drug enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Drug action (record #D-0197-2026) was formally reported on December 10, 2025, with the manufacturer initiating the action on October 31, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Cipla Limited is listed as the recalling firm, operating out of Pithampur, District Dhar. Federal records indicate 4,438 10x1mL cartons units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.
The documented reason for this recall is: Failed Stability Specifications: Observed OOS results: eg results for colour index Distribution data in the federal record shows the product reached: Nationwide in the USA. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
4,438 10x1mL cartons
Related Recalls
6
0 from same agency
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
Reason for Recall
Failed Stability Specifications: Observed OOS results: eg results for colour index
Details
- Recalling Firm
- Cipla Limited
- Units Affected
- 4,438 10x1mL cartons
- Distribution
- Nationwide in the USA
- Location
- Pithampur, District Dhar
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | D-0197-2026 |
| Date reported | December 10, 2025 |
| Date initiated | October 31, 2025 |
| Recalling firm | Cipla Limited |
| Units affected | 4,438 10x1mL cartons |
| Distribution | Nationwide in the USA |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cipla Limited. Units affected: 4,438 10x1mL cartons.
Why was this product recalled? ▼
Failed Stability Specifications: Observed OOS results: eg results for colour index
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 10, 2025. Severity: Moderate. Recall number: D-0197-2026.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0197-2026) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Recall Guides
Learn how the US recall system works and how to protect yourself and your household.
How the US Recall System Works
The three federal agencies, how recalls are initiated, and what happens next.
Understanding Recall Severity Classes
What Class I, II, and III mean and which recalls demand immediate action.
What to Do When a Product Is Recalled
Verify, claim your remedy, report injuries, and navigate the process.
How to Check If Your Products Are Recalled
Step-by-step guide to checking food, products, medications, and vehicles.
Recalled Products in Your Home
A room-by-room household audit guide for active recalls.
Most Recalled Product Categories
Rankings of highest-recall categories from FDA, CPSC, and NHTSA.
Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
Related Safety Data
Explore related product safety and public health data from federal sources.
Food Safety Inspections
FDA and state food facility inspection results — violations, enforcement actions, and compliance history for food manufacturers and processors.
PlainFoodSafe →
Ingredient Safety Data
FDA food additive and ingredient safety database — regulatory status, usage limits, and safety assessments for thousands of ingredients.
PlainIngredients →
Nutrition Data
USDA nutrition facts for 2M+ food items — calories, macros, vitamins, and ingredient analysis to verify what you consume.
GetFoodFacts →
Drug Safety Information
FDA drug data for 680+ medications — interactions, alternatives, side effects, and safety information for recalled and active drugs.
PlainMeds →
Product Injury Data
CPSC emergency room injury data for 838 product categories — 7.3M NEISS records tracking real-world consumer product injuries.
PlainSafety →
Recall Checker
Search our database of 83K+ recalls by product name, brand, or recall number across all agencies.
Check Now →
Recall Radar
Live feed of the latest recalls across FDA, CPSC, NHTSA, and USDA — filter by agency and severity.
View Radar →
Nearby Recalls in This Category
Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Amazon Recalls Amazon Basics Camping Folding Pocket Knives Due to Laceration Hazard
· 2026-03-19
FDA Food Moderate
Secondary Packaging: STEAM NOODLES INGREDIENTS: ENRICHED FLOUR, WATER, STARCH, SALT, POTASSIUM, CARBONATE AND BENZOATE …
CNC Noodle Corporation · 2026-03-18
FDA Food Moderate
Secondary Packaging: ZHONG HUA CHAO MIAN NOODLE INGREDIENTS: ENRICHED FLOUR, WATER, STARCH, SALT, POTASSIUM, CARBONATE …
CNC Noodle Corporation · 2026-03-18
FDA Food Moderate
VERGANI 1944 MILANO 'PANDORO CLASSICO' Gluten Free, 600g NET WT. 1 LBS. 5.2 OZ., packaged in paper cartons, 6 units per…
Italianway Import, Inc. · 2026-03-11
NHTSA Critical
CHEVROLET,GMC 2025: FUEL SYSTEM, GASOLINE:DELIVERY:FUEL PUMP:CONTROL/DRIVE MODULE
CHEVROLET,GMC · 2026-03-05
Compare this recall with Amazon Recalls Amazon Basics Camping Folding Pocket Knives … →
Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).