Dodex Cyanocobalamin Recall: Sub-potent Drug Risk
Accord Healthcare recalls Dodex Injectable Cyanocobalamin Injection due to sub-potent assay results. Check your lot number and expiration date.
Use caution until it’s fixed
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Contact the company
What happened, in plain English
Accord Healthcare, Inc. is recalling Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL because the drug was found to be sub-potent at the 9-month timepoint. This means the medication may not contain the full amount of active ingredient specified. The recall affects 4,574 cartons distributed nationwide in the USA. Read more at govinfonow.com/recall/33748-dodex-cyanocobalamin-recall-sub-potent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33748-dodex-cyanocobalamin-recall-sub-potent-drug-risk · Updated October 10, 2026 · FDA enforcement record: FDA #D-0528-2023
Cite this page
“Dodex Cyanocobalamin Recall: Sub-potent Drug Risk.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/33748-dodex-cyanocobalamin-recall-sub-potent-drug-risk. Based on FDA recall #D-0528-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0528-2023%22&limit=1).
Why it’s dangerous
The drug failed assay tests at the 9-month timepoint, resulting in a sub-potent product. This means the injection may deliver less than the labeled dose of cyanocobalamin (Vitamin B12), potentially leading to inadequate treatment of vitamin B12 deficiency.
Who’s affected
Patients who have been prescribed Dodex Injectable Cyanocobalamin Injection and possess the specific lot number R2200394 with an expiration date of 03/2024. Healthcare providers treating these patients are also affected.
How to tell if you have this one
Look for Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL in multiple dose vials. Specifically check for NDC 16729-533-08, Lot # R2200394, and an expiration date of 03/2024.
- Brand
Dodex- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Dodex injection matches NDC 16729-533-08, Lot # R2200394, and Exp. 03/2024.
Contact Your Provider
Consult your healthcare provider or pharmacist about the sub-potent risk and alternative treatment options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many cartons are affected by this recall?
Approximately 4,574 cartons are included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0528-2023 (March 29, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0528-2023 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.