Avion Pharmaceuticals, LLC Recall: Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.
United States
OngoingClass III
- Company
- Avion Pharmaceuticals, LLC
- Product
- Prenate Chewable¿ A chewable Rx prenatal vitamin with a deli…
- Recall date
- October 29, 2025
- Source
- FDA
Reason for recall
Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.
- - Recall initiated
- - Reported by source
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UPC 3 75854 30630 2 Manufactured for: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 | Not published in this source record | 804 bottles | Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02 |
Distribution
- Product was shipped to the following states: AL
- AZ
- CA
- CO
- FL
- GA
- IA
- IL
- KY
- MA
- MO
- NY
- OH
- OK
- PA
- TX & VA.
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- H-0233-2026
- Event ID
- 97893
- Status
- Ongoing
- Classification
- Class III
- Company
- Avion Pharmaceuticals, LLC
- Product description
- Prenate Chewable¿ A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary Supplement 30 Tablets Rx Only UPC 3 75854 30630 2 Manufactured for: Avion Pharmaceuticals, LLC Alpharetta, GA 30005
- Quantity
- 804 bottles
- Reason
- Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.
- Recall initiation date
- October 29, 2025
- Report date
- December 10, 2025
- Classification date
- Not published in this source record
- Termination date
- Not terminated as of this source record
- Distribution pattern
- Product was shipped to the following states: AL, AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NY, OH, OK, PA, TX & VA.
- UPC, lot, and code information
- Product Code 75854-306-30 Lot 2402036 Exp 2026-04 Lot 2402036A Exp 2026-04 & Lot 2412020 Exp 2027-02
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Letter
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: Avion Pharmaceuticals, LLC
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| Alabama | 1 |
| Arizona | 1 |
| California | 1 |
| Colorado | 1 |
| Florida | 1 |
| Georgia | 1 |
| Iowa | 1 |
| Illinois | 1 |
| Kentucky | 1 |
| Massachusetts | 1 |
| Missouri | 1 |
| New York | 1 |
| Ohio | 1 |
| Oklahoma | 1 |
| Pennsylvania | 1 |
| Texas | 1 |
| Virginia | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
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 III mean?
A situation in which use of or exposure to a product is not likely to cause adverse health consequences.
Is this recall still active?
According to FDA, this recall's status is "Ongoing." 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.
