Fiber Powder Dietary Supplement Recalled for Cronobacter sakazakii Contamination
Ortho Molecular Products is recalling fiber powder dietary supplements due to Cronobacter sakazakii detected in raw material. About 4,929 bottles distributed nationwide and to Canada are affected.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where raw material tested positive for Cronobacter sakazakii with no reported illnesses or injuries. This meets the severity rubric criterion for high-risk pathogen detection without reported illness.
Plain-English summary
Ortho Molecular Products, Inc. is recalling Fiber Plus and related fiber powder dietary supplements in apple cinnamon flavor. Products were packaged under multiple brand names including Ortho Molecular Products Fiber Plus, Utzy Naturals Daily Fiber Drink Mix, and unbranded bottles for healthcare provider distribution, with net weights ranging from 5.95 oz to 1000cc.
Raw material used in the products tested positive for Cronobacter sakazakii.
Approximately 4,929 bottles are affected. The recall involves lot numbers 87121 and 87059 with an expiration date of June 30, 2023. Products were distributed nationwide in the United States and to Canada.
Consumers who have these products should not use them.
The recalled product
- Product
- Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, packaged under the following brands and sizes. 1. Ortho Molecular Products Fiber Plus, Product #608445, Net Wt. 15.9 oz (450 Grams) UPC 6 15033-00608 2. Ortho Molecular Products, Inc., 3017 Business Park Drive…
- Manufacturer
- Ortho Molecular Products, Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 4,929
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lot 87121 Product Number 608445
- 608445C
- 608445CAN
- and 608445U UPC 615033006082
- 615033016081
- 615033046088
- and 615033606084 Expiration Date 06/30/23 Lot 87059 Product Number 608445
- UTZ100-1300168
- 608445U UPC 615033006082
- 615033606084
- and 856420006326 Expiration Date 06/30/23
Distribution
Distributed nationwide across the United States.
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