Ortho Molecular Products, Inc. Recall: Raw material tested positive for Cronobacter sakazakii.
United States
TerminatedClass II
- Company
- Ortho Molecular Products, Inc.
- Product
- Fiber Powder, Dietary Supplement, Apple Cinnamon Flavored, p…
- Recall date
- January 12, 2023
- Terminated
- April 9, 2024
- Source
- FDA
Reason for recall
Raw material tested positive for Cronobacter sakazakii.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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, Stevens Point, WI 54482. 2. Utzy Naturals, Daily Fiber Drink Mix. Net Wt 5.95 oz (168.75 Grams), UPC 8 56420-00632 6. Manufactured for Utzy Naturals, 623 West Main St., Lake Geneva, WI 53147. 3. Ortho Molecular Products Fiber Plus, Product #608445CAN, 450 g, UPC 6 15033-04608 8. Ortho Molecular Products, Inc. 54482 United States. Product is sold in Canada. 4. Ortho Molecular Products Fiber Plus, Product #608445C, Net Wt. 15.9 oz (450 Grams) UPC 6 15033-01608 1. . Ortho Molecular Products, Inc., 3017 Business Park Drive, Stevens Point, WI 54482. Contains CA Prop 65. 5. Unbranded bottled product in 1000cc bottle to be given out by healthcare provider. 608.008J UPC 6 15033 60608 4. 6. Unbranded bottled product in 1000cc bottle to be given out by healthcare provider. 608C.009H UPC 6 15033 61608 3. Contains CA Prop 65. | Not published in this source record | 4,929 bottles | 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, 608445C, 608445CAN, UTZ100-1300168, 608445U UPC 615033006082, 615033016081, 615033046088, 615033606084, and 856420006326 Expiration Date 06/30/23 |
Distribution
- Nationwide. Outside the US to Canada.
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-0340-2023
- Event ID
- 91515
- Status
- Terminated
- Classification
- Class II
- Company
- Ortho Molecular Products, Inc.
- Product description
- 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, Stevens Point, WI 54482. 2. Utzy Naturals, Daily Fiber Drink Mix. Net Wt 5.95 oz (168.75 Grams), UPC 8 56420-00632 6. Manufactured for Utzy Naturals, 623 West Main St., Lake Geneva, WI 53147. 3. Ortho Molecular Products Fiber Plus, Product #608445CAN, 450 g, UPC 6 15033-04608 8. Ortho Molecular Products, Inc. 54482 United States. Product is sold in Canada. 4. Ortho Molecular Products Fiber Plus, Product #608445C, Net Wt. 15.9 oz (450 Grams) UPC 6 15033-01608 1. . Ortho Molecular Products, Inc., 3017 Business Park Drive, Stevens Point, WI 54482. Contains CA Prop 65. 5. Unbranded bottled product in 1000cc bottle to be given out by healthcare provider. 608.008J UPC 6 15033 60608 4. 6. Unbranded bottled product in 1000cc bottle to be given out by healthcare provider. 608C.009H UPC 6 15033 61608 3. Contains CA Prop 65.
- Quantity
- 4,929 bottles
- Reason
- Raw material tested positive for Cronobacter sakazakii.
- Recall initiation date
- January 12, 2023
- Report date
- February 15, 2023
- Classification date
- Not published in this source record
- Termination date
- April 9, 2024
- Distribution pattern
- Nationwide. Outside the US to Canada.
- UPC, lot, and code information
- 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, 608445C, 608445CAN, UTZ100-1300168, 608445U UPC 615033006082, 615033016081, 615033046088, 615033606084, and 856420006326 Expiration Date 06/30/23
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Telephone
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: Ortho Molecular Products, Inc.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
