Dodex Injectable (Cyanocobalamin Injection) USP recall
FDA recall D-0580-2024 · initiated Jun 18, 2024
Accord Healthcare, Inc. recalled Dodex Injectable (Cyanocobalamin Injection) USP in Jun 2024 — an FDA Class III recall (D-0580-2024) because Subpotent drug: out of specification results.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Subpotent drug: out of specification results
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 52,998
Details
- Product
- 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 company
- Accord Healthcare, Inc.
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Jun 18, 2024
- FDA report date
- Jul 10, 2024
Frequently asked
- Was Dodex Injectable (Cyanocobalamin Injection) USP recalled?
- Accord Healthcare, Inc. recalled Dodex Injectable (Cyanocobalamin Injection) USP in Jun 2024 — an FDA Class III recall (D-0580-2024) because Subpotent drug: out of specification results. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Dodex Injectable (Cyanocobalamin Injection) USP recalled?
- Per the FDA enforcement record, the reason for recall D-0580-2024 was: Subpotent drug: out of specification results
- Is a recalled Dodex Injectable (Cyanocobalamin Injection) USP dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Dodex Injectable (Cyanocobalamin Injection) USP are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot# 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. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0580-2024.