CLASS III Drug recall · Reported 15 Jan 2014 · FDA Enforcement Report
Fenofibric Acid, immediate release tablet, 105 mg, a) bottle recalled
Mutual Pharmaceutical is recalling Fenofibric Acid, immediate release tablet, 105 mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 27 Feb 2013 and the FDA has classified it as Class III.
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-400-2014
- FDA event ID
- 64727
- Recalling firm
- Mutual Pharmaceutical, Philadelphia, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Feb 2013
- FDA classified
- 6 Jan 2014
- Reported
- 15 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 27 Feb 2013 | Recall initiated by company | |
| 6 Jan 2014 | Classified by FDA | +313 days |
| 15 Jan 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Product as listed by the FDA
Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots
Which lots are affected?
lot 6581105 & 6581106 exp. 07/15, and lot 6623001 & 6623002 exp. 01/16
Where was it sold?
Nationwide and Puerto Rico.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 64727| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Fibricor (fenofibric acid) Tablets, 105 mg, a) bottle recalled | Mutual Pharmaceutical | Other | Nationwide | |
| CLASS III | Fenofibric Acid, immediate release tablet, 35 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
More recalls from Mutual Pharmaceutical
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalled | Mutual Pharmaceutical | Other | MS |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 10 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 25 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 50 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Felodipine Extended-Release Tablets, 5 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
Other Fenofibric Acid recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fenofibric Acid Tablets, 35 mg, labeled as a) Fibricor recalled | Tribute Pharmaceuticals US | Other | Nationwide |
| Drug | CLASS III | Fenofibric Acid Tablets 105 mg recalled by Tribute Pharmaceuticals US | Tribute Pharmaceuticals US | Other | Nationwide |
| Drug | CLASS III | Fenofibric Acid, immediate release tablet, 35 mg recalled | Mutual Pharmaceutical | Other | Nationwide |