CLASS II Drug recall · Reported 31 Oct 2012 · FDA Enforcement Report
Simply Right Healthcare Fiber Capsules recalled
Raritan Pharmaceuticals is recalling Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, 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-029-2013
- 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
Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716, UPC 0-78742-00524-9.
Where it was distributed
Nationwide
Questions about this recall
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?
Lots 16273, Exp 06/15; 16460, 16464, 16466, 16468, 16469, Exp 07/15
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 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
11 other products · FDA event 63384This product is part of a recall event; the main page for the event is Premier Value Fiber Capsules, Fiber Capsules recalled.