# FDA recall D-0007-2023

> **Dr. Reddy's Laboratories, Inc.** · Class III · drug recall initiated 2022-09-14.

## Product

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

## Reason for recall

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

## Distribution

USA nationwide

## Key facts

- **Recall number:** D-0007-2023
- **Recalling firm:** Dr. Reddy's Laboratories, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Completed
- **Initiation date:** 2022-09-14
- **Report date:** 2022-10-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2023

## Citation

> AI Analytics. FDA recall D-0007-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/D-0007-2023. Source: US FDA. Licensed CC0.

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