Food recall: Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTA
Professional Complementary Health Formulas, LLC (Lake Oswego, OR) initiated this food recall on 20 Dec 2021; FDA lists 2 product records under event 91377, classified Class II.
FDA defines Class II as 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. 57% of the 463 food enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 3 Apr 2023. Initiation: voluntary: firm initiated. Professional Complementary Health Formulas, LLC has 2 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Professional Complementary Health Formulas, LLC, Lake Oswego, OR.
Reason for recall
"Product recalled due to undeclared niacin."
Distribution
"Inositol was distributed in NY, OR, PA, UT, WI, and WY. Vitamin B Complex was distributed nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| F-0322-2023 | Inositol packaged in white plastic bottle with UPC 4065111562 and labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Inositol DIETARY SUPPLEMENT 360 Capsules***Supplement Facts Serving Size: One Capsule***Inositol 920 mg***Other Ingredients: Vegetarian capsule (hypromellose and water) and vegetable… | 40 bottles | Class II | Terminated | 8 Feb 2023 |
| F-0323-2023 | Vitamin B Complex packaged in white plastic bottle labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Vitamin B Complex DIETARY SUPPLEMENT 60 Capsules***Supplement Facts Serving Size: One Capsule***Vitamin B1 (as thiamine Hcl) 80mg 6667% Vitamin B2 (as riboflavin) 80 mg 6154% Vitamin B3 (as niacinamide)… | 299 bottles | Class II | Terminated | 8 Feb 2023 |
Context
Other enforcement events for Professional Complementary Health Formulas, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Jul 2017 | Professional Formulas Sublinqual B12 High-Potency dietary supplement, 60-count dissolvable tablet in white plastic bottl (77806) | Food | Class II | 1 |
Questions and answers
Why was this food recalled?
FDA's record gives the reason for recall as: "Product recalled due to undeclared niacin."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "Inositol was distributed in NY, OR, PA, UT, WI, and WY. Vitamin B Complex was distributed nationwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 3 Apr 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA food enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.