Vitamin B Complex packaged in white plastic bottle labeled in part, "***PROFE...
FDA Recall #F-0323-2023 — Class II — December 20, 2021
Recall Summary
| Recall Number | F-0323-2023 |
| Date Initiated | December 20, 2021 |
| Classification | Class II |
| Status | Terminated |
| Type | Voluntary: Firm initiated |
| Product Type | Food |
Recalling Firm
| Firm | Professional Complementary Health Formulas, LLC |
| Location | Lake Oswego, OR |
Product Description
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) 80 mg NE 500% Vitamin B6 (as pyridoxine HCl) 80 mg 4706% Folic acid 667 mcg DFE 167% Vitamin B12 (as cyanocobalamin) 80 mcg 3333% Biotin 300 mcg 1000% Vitamin B5 (as calcium pantothenate) 80 mg 1600% Choline (as bitartrate) 80 mg 15%***Professional Formulas PO Box 2034, Lake Oswego, OR 97035 Recommended Dosage: As a nutritional supplement, take one capsule, or as directed by your healthcare professional***FOR PROFESSIONAL USE ONLY"
Reason for Recall
Product recalled due to undeclared niacin.
Classification
Class II — 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.
Distribution Pattern
Inositol was distributed in NY, OR, PA, UT, WI, and WY. Vitamin B Complex was distributed nationwide.
Product Quantity
299 bottles
Product Codes / Lot Numbers
Lot 1092715
What Should You Do?
Stop consuming this product immediately. Check your home for the recalled item and dispose of it safely. If you experienced a health issue after consuming this product, contact your doctor and report it to the FDA MedWatch.
Frequently Asked Questions
Stop consuming the product immediately and do not donate or give it to others. Check the recall notice above for specific disposal or return instructions. Many food recalls ask you to throw the product away and retain the packaging for a possible refund from the retailer. If you purchased it online, check your order history — some retailers send recall notifications directly to customers. You do not need a receipt to report an issue or seek a refund; the fact of purchase is typically sufficient.
If you have a food allergy and consumed the recalled product, monitor yourself closely for allergic reaction symptoms — including hives, swelling, difficulty breathing, nausea, vomiting, or anaphylaxis. If you experience any symptoms, seek medical attention immediately. For anaphylaxis (severe allergic reaction with difficulty breathing, rapid heartbeat, or loss of consciousness), call 911 and use an epinephrine auto-injector (EpiPen) if available. Stop consuming the product and check all products from the same manufacturer for similar labeling issues, as undeclared allergens sometimes affect multiple products from the same production facility.
Report foodborne illnesses and adverse food reactions to the FDA through the MedWatch Safety Reporting Portal at FDA.gov, or by calling 1-800-332-1088. You can also report issues directly to the FDA's Safety Reporting Portal at SafetyReporting.hhs.gov. If you believe there is an immediate public health risk, contact your local health department. Your report helps the FDA identify contamination patterns, initiate recalls faster, and protect other consumers from the same hazard. Include as much detail as possible: the product name, lot code, purchase date and location, and a description of your symptoms or findings.
The FDA assigns a status to each recall action throughout its lifecycle. "Ongoing" means the recall is active — the firm is still working to remove the product from commerce and notify consumers. "Completed" means the recall strategy has been implemented and the FDA has determined that the recalling firm has taken all appropriate steps to remove the product. "Terminated" means the FDA has reviewed the results and concluded the recall is complete. Even if a recall is marked as completed or terminated, you should still discard any recalled products you find at home — the recall status refers to the firm's compliance actions, not the safety of product still in consumers' possession.