Raritan Pharmaceuticals Berkley & Jensen Fiber Capsules Recall

Why it was recalled

Microbial Contamination of Non-Sterile Products: Product is being recalled due to possible microbial contamination by C. difficile discovered in the raw material.

Product description

Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2.

Lot numbers, UPCs & expiration codes

Lot 16470, Exp 08/15

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-028-2013
Classification: Class II
Status: Terminated
Recall initiated: Sep 4, 2012
FDA report date: Oct 31, 2012
Quantity: 3,552 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Raritan Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-028-2013, exactly as published.

Show all FDA fields

City: East Brunswick
State: NJ
Status: Terminated
Country: United States
Event ID: 63384
Address: 8 Joanna Ct
Code information: Lot 16470, Exp 08/15
Postal code: 08816-2108
Report date: Oct 31, 2012
Product type: Drugs
Recall number: D-028-2013
Classification: Class II
Recalling firm: Raritan Pharmaceuticals, Inc.
Product quantity: 3,552 bottles
Termination date: Oct 7, 2014
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.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC 4-00016-27053-2.
Distribution pattern: Nationwide
Recall initiation date: Sep 4, 2012
Initial firm notification: E-Mail
Center classification date: Oct 25, 2012

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-028-2013, published Oct 31, 2012. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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