Medications & Supplements/Prescription Drugs

Primus Pharmaceuticals, Inc.: Limbrel Capsules Recalled for Being Unapproved and Untested Drugs

Agency Publication Date: February 9, 2018

Summary

Primus Pharmaceuticals is recalling approximately 307,598 bottles of Limbrel (flavocoxid) and Limbrel250/Limbrel500 (flavocoxid and citrated zinc bisglycinate) capsules because they are being marketed without FDA approval. The FDA has determined these products are unapproved drugs rather than medical foods, meaning their safety, effectiveness, and manufacturing quality have not been verified. These prescription-only products were distributed nationwide in 60-count bottles. Consumers currently taking these medications should stop using them and consult their healthcare provider for alternative treatment options.

Risk

The safety and efficacy of these capsules have not been established by the FDA. Because these products are unapproved drugs, there is no guarantee they are safe for consumption or effective at treating the conditions for which they are prescribed.

What You Should Do

Check your medicine cabinet for bottles of Limbrel (flavocoxid 250 mg or 500 mg) or Limbrel250/Limbrel500 (flavocoxid and citrated zinc bisglycinate) capsules.
Look for the following NDC (National Drug Code) numbers on the bottle label: 68040-601-16, 68040-602-16, 68040-605-16, or 68040-606-16.
Verify if your product is within its expiration date, as all lots that have not yet expired are included in this recall.
Stop using the product immediately if it matches the identified NDC numbers and expiration status.
Contact your healthcare provider or pharmacist to discuss your health concerns and to find an approved alternative treatment.
Return any unused product to the pharmacy where it was purchased for a refund and contact Primus Pharmaceuticals at their Scottsdale, Arizona headquarters for further instructions.
For additional questions or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Consult healthcare provider and return product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Limbrel (flavocoxid 250 mg) capsules (60-count bottle)

Model:

NDC 68040-601-16

Lot Numbers:

All lots within expiry

Product: Limbrel (flavocoxid 500 mg) capsules (60-count bottle)

Model:

NDC 68040-602-16

Lot Numbers:

All lots within expiry

Product: Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules (60-count bottle)

Model:

NDC 68040-605-16

Lot Numbers:

All lots within expiry

Product: Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules (60-count bottle)

Model:

NDC 68040-606-16

Lot Numbers:

All lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 79055

Status: Resolved

Manufacturer: Primus Pharmaceuticals, Inc.

Sold By: Pharmacies (Rx only)

Manufactured In: United States

Units Affected: 4 products (7,826 bottles; 135,277 bottles; 4,006 bottles; 160,489 bottles)

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

Check your medicine cabinet for bottles of Limbrel (flavocoxid 250 mg or 500 mg) or Limbrel250/Limbrel500 (flavocoxid and citrated zinc bisglycinate) capsules.

Look for the following NDC (National Drug Code) numbers on the bottle label: 68040-601-16, 68040-602-16, 68040-605-16, or 68040-606-16.

Verify if your product is within its expiration date, as all lots that have not yet expired are included in this recall.

Stop using the product immediately if it matches the identified NDC numbers and expiration status.

Contact your healthcare provider or pharmacist to discuss your health concerns and to find an approved alternative treatment.

Return any unused product to the pharmacy where it was purchased for a refund and contact Primus Pharmaceuticals at their Scottsdale, Arizona headquarters for further instructions.

For additional questions or to report adverse effects, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Limbrel (flavocoxid 250 mg) capsules (60-count bottle)

Model:

NDC 68040-601-16

Lot Numbers:

All lots within expiry

Product: Limbrel (flavocoxid 500 mg) capsules (60-count bottle)

Model:

NDC 68040-602-16

Lot Numbers:

All lots within expiry

Product: Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules (60-count bottle)

Model:

NDC 68040-605-16

Lot Numbers:

All lots within expiry

Product: Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules (60-count bottle)

Model:

NDC 68040-606-16

Lot Numbers:

All lots within expiry