CLASS I Drug recall · Reported 21 Feb 2018 · FDA Enforcement Report
Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg recalled
Primus Pharmaceuticals is recalling Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg, distributed nationwide in the US. The recall was initiated on 26 Jan 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0347-2018
- FDA event ID
- 79055
- Recalling firm
- Primus Pharmaceuticals, Scottsdale, AZ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 26 Jan 2018
- FDA classified
- 9 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Hidden Drug Ingredients
Timeline
| 26 Jan 2018 | Recall initiated by company | |
| 9 Feb 2018 | Classified by FDA | +14 days |
| 21 Feb 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg recalled?
Yes. Primus Pharmaceuticals recalled Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg on 26 Jan 2018. The recall is Class I and its status is Terminated. Recall number D-0347-2018.
Why was it recalled?
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.
Which lots are affected?
All lots within expiry.
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Primus Pharmaceuticals
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg recalled | Primus Pharmaceuticals | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS I | Limbrel (flavocoxid 250 mg) capsules recalled by Primus Pharmaceuticals | Primus Pharmaceuticals | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS I | Limbrel (flavocoxid 500 mg) capsules recalled by Primus Pharmaceuticals | Primus Pharmaceuticals | Hidden Drug Ingredients | Nationwide |