Class III · Lower riskRecall completed
Dodex Injectable (Cyanocobalamin Injection) USP
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot# R2200834, R2200835, R2200841, R2200958, Exp 06/30/2024; R2201044 R2201045 R2201046, R2201047, R2201095, R2201142, R2201143, R2201144, Exp 07/31/2024; M2215870, M2215918, Exp 10/2024
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Subpotent drug: out of specification results
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byIntas Pharmaceuticals Limited, Ahmedabad-382 210, India foreign manufacturer
| Distributed by / for | Accord Healthcare, Inc., Durham, NC 27703 |
| NDC | 16729-533-08 |
Show the full FDA record
| Full product label | Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India, NDC 16729-533-08, UPC Code: 031672953308 |
| Recalling firm | Accord Healthcare, Inc. |
| Distribution | USA Nationwide |
| Quantity | 52,998 |
| Recall initiated | 2024-06-18 |
| Report date | 2024-07-10 |
| Recall completed | 2026-02-12 |
| Recall number | D-0580-2024 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Durham NC United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.