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RECALL RECORD — CLASS IIRecall closedF-1295-2019/FDA enforcement
Cays LLC·Dietary Supplements·Mar 29, 2019

Addback Tablet Dietary Supplement 60 Tablets Per 190cc Oblong Whdpe Bottle NET Wet: 85gm (60…

What you need to know

Class II

  • What happened

    Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is…

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. An allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

  • 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 FDAINMore supplements

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Match before you discard

Product identification

Source: FDA FOOD

Brand nameCays LLC
Recalling firmCays LLCSouthington, CT, United States
UPC / barcodes
0 651536 12452 6
Lot / date codes
  • Code NS-1930F Lot # 1810553 Exp. Date 12/2020
Distribution area
IN

All product is in the firm's possession.

United States

Quantity affected2095 bottles
Recall initiationFDA report date: April 24, 2019
FDA recall numberF-1295-2019

Beyond the headline

The recall, in context

Cays LLC initiated this supplements recall on March 29, 2019. The FDA enforcement report states: Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is not part of the formulation. The FDA report lists distribution as: All product is in the firm's possession.

The FDA enforcement report describes the reason as: Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is not part of the formulation

Addback Tablet Dietary Supplement 60 Tablets Per 190cc Oblong Whdpe Bottle NET Wet: 85gm (60… was made or distributed by Cays LLC in Southington, CT, United States. This page reflects FDA report F-1295-2019, dated April 24, 2019.

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, an allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

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 allergen

Symptoms to watch for

Hives, swelling, wheezing, coughing, vomiting, abdominal pain or a drop in blood pressure. Anaphylaxis is a medical emergency.

When symptoms may appear

Allergic reactions often begin within minutes to a few hours of eating the allergen.

Higher-risk groups

Anyone with a diagnosed food allergy, especially children, and people with a history of anaphylaxis or asthma.

What to do now

  1. 1Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy.
  2. 2If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services.
  3. 3Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

For a severe allergic reaction, do not wait for a callback or refund process before seeking emergency care.

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 Addback Tablet Dietary Supplement 60 Tablets Per 190cc Oblong Whdpe Bottle NET Wet: 85gm (60… recall?

Cays LLC recalled Addback Tablet Dietary Supplement 60 Tablets Per 190cc Oblong Whdpe Bottle NET Wet: 85gm (60… in an FDA Class II enforcement action reported as F-1295-2019. Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is…

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 or serve the affected product if you or anyone in the household has a diagnosed allergy. If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services. Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

Is the Cays 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-1295-2019. 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

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