CLASS II Drug recall · Reported 31 Oct 2012 · FDA Enforcement Report
Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative recalled
Raritan Pharmaceuticals is recalling Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, distributed nationwide in the US. The recall was initiated on 4 Sep 2012 and the FDA has classified it as Class II.
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-024-2013
- FDA event ID
- 63384
- Recalling firm
- Raritan Pharmaceuticals, East Brunswick, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2012
- FDA classified
- 25 Oct 2012
- Reported
- 31 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
Timeline
| 4 Sep 2012 | Recall initiated by company | |
| 25 Oct 2012 | Classified by FDA | +51 days |
| 31 Oct 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH 43017 www.myleader.com, NDC 37205-372-78, UPC 0-96295-11222-1.
Where it was distributed
Nationwide
Questions about this recall
Is Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement recalled?
Yes. Raritan Pharmaceuticals recalled Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement on 4 Sep 2012. The recall is Class II and its status is Terminated. Recall number D-024-2013.
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.
Which lots are affected?
CIN 3510963; Lots 16273,16274, Exp 06/15
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.