Primus Limbrel capsules unapproved drug recall - Safety concerns
Primus Pharmaceuticals recalls unapproved Limbrel capsules (flavocoxid 500mg) due to lack of FDA approval. These products have not been proven safe or effective and may pose health risks.
Recall notice
Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall.
Contact the company
What happened, in plain English
Primus Pharmaceuticals is recalling Limbrel (flavocoxid 500 mg) capsules because they were marketed without FDA approval. This means the product's safety and effectiveness have not been established, potentially putting users at risk. Read more at govinfonow.com/recall/40904-primus-limbrel-capsules-unapproved-drug-recall-safety-concerns.
Source Summary by GovInfoNow · govinfonow.com/recall/40904-primus-limbrel-capsules-unapproved-drug-recall-safety-concerns · Updated October 7, 2026 · FDA enforcement record: FDA #D-0345-2018
Cite this page
“Primus Limbrel capsules unapproved drug recall - Safety concerns.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40904-primus-limbrel-capsules-unapproved-drug-recall-safety-concerns. Based on FDA recall #D-0345-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0345-2018%22&limit=1).
Why it’s dangerous
The product was marketed without FDA approval, meaning its safety and effectiveness have not been proven through proper clinical trials. This could lead to health risks that are not known to the public.
Who’s affected
People who have been prescribed Limbrel capsules by a doctor. Those using the unapproved product without medical supervision are at higher risk.
How to tell if you have this one
Check for Limbrel (flavocoxid 500 mg) capsules in 60-count bottles with NDC 68040-602-16. The product is prescription-only and was manufactured by Cornerstone Research and Development in Ogden, UT.
- Brand
Primus Pharmaceuticals- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Nationwide in the USA.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0344-2018 | Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-601-16.; All lots within expiry. | 7,826 bottles |
| D-0345-2018 | Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-602-16.; All lots within expiry. | 135,277 bottles |
| D-0346-2018 | Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-605-16.; All lots within expiry. | 4,006 bottles |
| D-0347-2018 | Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-606-16.; All lots within expiry. | 160,489 bottles |
What to do — step by step
Check Product Details
Look for the product name, strength, and NDC number on the packaging to confirm it matches the recalled items.
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 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0345-2018 (January 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0345-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.