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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cape Drugs Injectable Medications Recalled for Lack of Processing Controls

Agency Publication Date: December 15, 2021
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Summary

Valgene Incorporated, doing business as Cape Drugs, is recalling 39 vials of sterile injectable medications including Methylcobalamin (12mg/ml) and B-Complex. The recall affects 27 vials of Methylcobalamin and 12 vials of B-Complex that were distributed only in Maryland. The medications are being recalled because of a lack of processing controls, which could compromise the quality and sterility of the drugs. No injuries or illnesses have been reported to date.

Risk

The lack of processing controls for these sterile injectable drugs means the medications could be contaminated or fail to meet quality standards. Using improperly processed sterile injections could lead to serious health complications or infections.

What You Should Do

  1. This recall affects Cape Drugs brand Methylcobalamin 12mg/ml injection (1 mL vials, Lot 188008, BUD 03/19/2022) and B-Complex injection (1 mL vials, Lot 190036, BUD 12/27/2021).
  2. Stop using the recalled product immediately.
  3. Contact Valgene Incorporated (doing business as Cape Drugs) at its Annapolis, Maryland location or your distributor to arrange for the return of any unused medication.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Methylcobalamin 12mg/ml injection (1 mL vials)
Variants: 12mg/ml, 1 mL vials, Rx only
Lot Numbers:
188008 (BUD 03/19/2022)

Quantity: 27 vials

Product: B-Complex injection (1 mL vials)
Variants: 1 mL vials, Rx only
Lot Numbers:
190036 (BUD 12/27/2021)

Quantity: 12 vials

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89209
Status: Resolved
Manufacturer: Valgene Incorporated dba Cape Drugs
Sold By: Cape Drugs
Manufactured In: United States
Units Affected: 2 products (27 vials; 12 vials)
Distributed To: Maryland

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.