Phytonadione Injectable Emulsion USP — Class III drug recall D-0007-2023
Completed recall by Dr. Reddy's Laboratories, Inc., reported 2022-10-12, distributed nationwide. Failed Stability Specifications: Out of specification results reported at 12-month stability testing for alumi
| Recall number | D-0007-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2022-09-14 |
| Classified | 2022-10-06 |
| Reported by FDA | 2022-10-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,838 ampules |
| Reason classes | specification failure |
| NDC | 43598-0405, 43598-0405-11, 43598-0405-16 |
| Lot numbers | ACB101 |
| Expiration dates | 2023-03 |
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.
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-0007-2023. 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.