RECALL RECORD — CLASS IIRecall closedF-3348-2017/FDA enforcement

Professional Formulas Sublinqual B12 High-potency Dietary Supplement, 60-count Dissolvable…

What you need to know

Class II
  • What happened

    Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

  • Action required

    Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.

Recall closed · classified by the FDAIN, AZ, CA, CO +30 moreMore supplements

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Product identification

Source: FDA FOOD

Brand nameProfessional Complementary Health Formulas, LLC
Recalling firmProfessional Complementary Health Formulas, LLCLake Oswego, OR, United States
UPC / barcodes
8 40851 10054 0
Lot / date codes
  • Lot numbers: 409017; 503019; 508060; 603032; and 701039. QR Codes: 1409002; 1505019
  • 1603007; 1607022; and 1701013. QR codes are interpreted as below: " The first two digits represent the year in which the product was ordered or manufactured; " The second two digits represent the month in which the product was ordered or manufactured; and " The last three digits represent the products place in a sequential list of products ordered during that month and year.
Distribution area
INAZCACOCTFLGAHIIDILKSLAMAMDMEMIMTNCNJNMNVNYOHOKORPARISCSDTNTXUTWAWI

distributed in AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, and WI and in the following countries: Canada and United Kingdom

United States, Canada, United Kingdom

Quantity affected2178/60 tablets Bottles
Recall initiationFDA report date: August 9, 2017
FDA recall numberF-3348-2017

Beyond the headline

The recall, in context

Professional Complementary Health Formulas, LLC initiated this supplements recall on July 21, 2017. The FDA enforcement report states: Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk. The FDA report lists distribution as: distributed in AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, WA, and WI and in the following countries: Canada and United Kingdom.

The FDA enforcement report describes the reason as: Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.

Professional Formulas Sublinqual B12 High-potency Dietary Supplement, 60-count Dissolvable… was made or distributed by Professional Complementary Health Formulas, LLC in Lake Oswego, OR, United States. This page reflects FDA report F-3348-2017, dated August 9, 2017.

Why this is a Class II recall

Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.

FDA definition

The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.

What to do now

  1. 1

    Stop using it

    Do not eat, drink or take the affected product.

  2. 2

    Check the codes

    Compare the UPC and lot code against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Undeclared milk

Symptoms to watch for

Hives, swelling, wheezing, vomiting or anaphylaxis can occur in people with a milk allergy.

When symptoms may appear

Reactions can begin within minutes to a few hours after eating the product.

Higher-risk groups

People with a diagnosed cow's milk allergy, especially children and anyone with a history of anaphylaxis.

What to do now

  1. 1Do not eat the product if you have a milk allergy.
  2. 2Seek emergency care for breathing difficulty, throat swelling or other signs of anaphylaxis.
  3. 3Keep the packaging and contact the retailer or manufacturer about a refund.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Professional Formulas Sublinqual B12 High-potency Dietary Supplement, 60-count Dissolvable… recall?

Professional Complementary Health Formulas, LLC recalled Professional Formulas Sublinqual B12 High-potency Dietary Supplement, 60-count Dissolvable… in an FDA Class II enforcement action reported as F-3348-2017. Sublinqual B12 tablets are recalled because the ingredients statement declared lactose but label does not declare milk.

What are the symptoms of Undeclared milk exposure?

Hives, swelling, wheezing, vomiting or anaphylaxis can occur in people with a milk allergy.

How quickly can Undeclared milk symptoms appear?

Reactions can begin within minutes to a few hours after eating the product.

Who is most at risk from Undeclared milk?

People with a diagnosed cow's milk allergy, especially children and anyone with a history of anaphylaxis.

What should I do if I bought this product?

Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. Do not eat the product if you have a milk allergy. Seek emergency care for breathing difficulty, throat swelling or other signs of anaphylaxis. Keep the packaging and contact the retailer or manufacturer about a refund.

How do I get a refund from Professional Complementary Health Formulas, LLC?

Contact the recalling company or the retailer where you purchased the product, quote the FDA recall number and ask about a refund or replacement. Keep the packaging, lot code and proof of purchase where possible. The FDA does not issue consumer refunds. Reference FDA recall F-3348-2017 and keep the packaging, lot code and proof of purchase if you have them.

Is the Professional Complementary Health Formulas, LLC recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record F-3348-2017. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

Brand history

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Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.