Professional Formulas Recalls Sublinqual B12 Tablets Due to Undeclared Milk
Professional Complementary Health Formulas, LLC is recalling Sublinqual B12 High-Potency tablets because the label fails to declare milk, a major allergen, despite lactose being listed in the ingredients.
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: The recall involves allergen mislabeling on a common allergen (milk), which corresponds to a severity score of 3 (High) according to the rubric, as no illnesses or injuries are reported in the source text.
Plain-English summary
Professional Complementary Health Formulas, LLC is voluntarily recalling specific lots of Professional Formulas Sublinqual B12 High-Potency dietary supplements. The product consists of 60-count dissolvable tablets in white plastic bottles with a heat-shrink band. The recall is necessary because the ingredients statement declares lactose, but the label does not declare milk, which is a major food allergen.
The affected product was distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Montana, North Carolina, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, and Wisconsin, as well as in Canada and the United Kingdom. The specific lot numbers involved are 409017, 503019, 508060, 603032, and 701039. Corresponding QR codes are 1409002, 1505019, 1603007, 1607022, and 1701013.
Consumers with these products should stop using them and contact the recalling firm for instructions on how to return the product or obtain a refund. Individuals with a milk allergy should be particularly cautious and consult a healthcare provider if they have consumed the product.
The recalled product
- Product
- Professional Formulas Sublinqual B12 High-Potency dietary supplement, 60-count dissolvable tablet in white plastic bottles. Adhesive label with White, black red and green print; bottle has a heat-shrink band. UPC code 8 40851 10054 0.
- Manufacturer
- Professional Complementary Health Formulas, LLC
- Category
- Food — Dietary Supplement
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 (8)
- Lot numbers: 409017
- 503019
- 508060
- 603032
- and 701039. QR Codes: 1409002
- 1505019
- 1603007
- 1607022
Distribution
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