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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Dodex (Cyanocobalamin) Injectable Recalled for Subpotency

Agency Publication Date: July 2, 2024
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Summary

Accord Healthcare, Inc. is recalling 52,998 units of Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, which is a prescription vitamin B12 supplement. The recall was issued because laboratory results found the drug to be subpotent, meaning it does not contain the full strength of the active ingredient as required. If you are using this medication, please contact your healthcare provider or pharmacist for guidance regarding your treatment.

Risk

A subpotent drug may not provide the intended therapeutic dose of vitamin B12, which could result in ineffective treatment for patients with B12 deficiencies. No specific injuries or adverse events were reported in this recall notice.

What You Should Do

  1. This recall affects Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, sold in 1mL multiple dose vials with NDC 16729-533-08 and UPC 031672953308.
  2. Identify your vial or carton and check the lot number and expiration date. Affected lots include R2200834, R2200835, R2200841, R2200958, R2201044, R2201045, R2201046, R2201047, R2201095, R2201142, R2201143, R2201144, M2215870, and M2215918. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Accord Healthcare, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Dodex Injectable (Cyanocobalamin Injection) USP (1mL)
Variants: 1,000mcg/mL, Multiple dose vial, Rx only
UPC Codes:
031672953308
Lot Numbers:
R2200834 (Exp 06/30/2024)
R2200835 (Exp 06/30/2024)
R2200841 (Exp 06/30/2024)
R2200958 (Exp 06/30/2024)
R2201044 (Exp 07/31/2024)
R2201045 (Exp 07/31/2024)
R2201046 (Exp 07/31/2024)
R2201047 (Exp 07/31/2024)
R2201095 (Exp 07/31/2024)
R2201142 (Exp 07/31/2024)
R2201143 (Exp 07/31/2024)
R2201144 (Exp 07/31/2024)
M2215870 (Exp 10/2024)
M2215918 (Exp 10/2024)
NDC:
16729-533-08

Manufactured for Accord Healthcare by Intas Pharmaceuticals Limited.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94842
Status: Resolved
Manufacturer: Accord Healthcare, Inc.
Manufactured In: United States, India
Units Affected: 52,998
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.