Use caution Drug recall · FDA · Published June 18, 2024

Recall: Dodex Injectable (Cyanocobalamin) Subpotent Drug Hazard

Accord Healthcare recalls Dodex Injectable due to subpotent drug results. Check lot numbers R2200834, R2201144 and expiration dates before use.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0580-2024Drug Accord Healthcare ›

Use caution until it’s fixed

Subpotent drug: out of specification results

Take action

Contact the company

Recalling firmAccord Healthcare, Inc.1009 Slater Rd Ste 210B · Durham, NC 27703-8446

✎ GovInfoNow plain-language explainer

Accord Healthcare is recalling Dodex Injectable (Cyanocobalamin Injection) USP because the product was found to be subpotent and out of specification. This means the medication may not contain the full amount of active ingredient needed for effective treatment. The recall affects multiple lots distributed nationwide in the USA. Read more at govinfonow.com/recall/32626-recall-dodex-injectable-cyanocobalamin-subpotent-drug-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/32626-recall-dodex-injectable-cyanocobalamin-subpotent-drug-hazard · Updated October 9, 2026 · FDA enforcement record: FDA #D-0580-2024

Cite this page

“Recall: Dodex Injectable (Cyanocobalamin) Subpotent Drug Hazard.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/32626-recall-dodex-injectable-cyanocobalamin-subpotent-drug-hazard. Based on FDA recall #D-0580-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0580-2024%22&limit=1).

Accord Healthcare, Inc. recalled Dodex Injectable (Cyanocobalamin Injection) USP on June 18, 2024, due to subpotent drug results, the FDA announced. The voluntary Class III recall affects 52,998 units distributed nationwide in the USA.

How to tell if you have it

Brand: Accord Healthcare
Product: Dodex Injectable Cyanocobalamin
NDC: 16729-533-08
UPC Code: 031672953308
Lot codes: 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)

The hazard

The product poses a subpotent drug hazard because it produced out of specification results. The recall classification is Class III.

Context

GovInfoNow's records show Accord Healthcare, Inc. has 16 other recalls on record since Dec. 20, 2016. Other recent recalls of similar products include Accord Healthcare Levothyroxine Tablets Recall (Aug. 6, 2026), Accord Healthcare recalls Levothyroxine tablets (June 8, 2026), and Accord Healthcare Levothyroxine Tablets Recall (Sept. 16, 2025). Other recent recalls of similar products include Gasco Isopropyl Alcohol 70% Recall (May 29, 2026), CoValence Laboratories Remedy Gel Hydrocortisone 1% Recall (March 18, 2026), and Gasco Industrial Isopropyl Alcohol 70% Recall (May 29, 2026).

How to tell if you have this one

Check your vial for the NDC 16729-533-08 and UPC Code 031672953308. Verify if the lot number is one of the following: R2200834, R2200835, R2200841, R2200958 (Exp 06/30/2024); R2201044, R2201045, R2201046, R2201047, R2201095, R2201142, R2201143, R2201144 (Exp 07/31/2024); or M2215870, M2215918 (Exp 10/2024).

Brand
Accord Healthcare
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using the medication
Do not use any vials matching the recalled lot numbers and expiration dates listed in the record.
Contact your healthcare provider
Speak with your doctor or pharmacist immediately to discuss alternative treatment options or replacement medication.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

Jun 18, 2024Firm started the recall
Jul 2, 2024FDA classified it Class III
Jul 10, 2024Published in FDA’s Enforcement Report
Feb 12, 2026FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Accord Healthcare recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/32626-recall-dodex-injectable-cyanocobalamin-subpotent-drug-hazard">Recall: Dodex Injectable (Cyanocobalamin) Subpotent Drug Hazard (GovInfoNow)</a>

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-0580-2024 (June 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0580-2024 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.