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RECALL RECORD — CLASS IIIRecall closedF-0397-2018/FDA enforcement
Pure Encapsulations, INC.·Dietary Supplements·Nov 17, 2017

Pure Encapsulations Ai Enzymes Dietary Supplement 120 Capsules

What you need to know

Class III

  • What happened

    Product contains undeclared sulfites.

  • Health risk

    The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. 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 FDANH, AZ, CO, OH +1 moreMore supplements

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Product identification

Source: FDA FOOD

Brand namePure Encapsulations, INC.
Recalling firmPure Encapsulations, INC.Sudbury, MA, United States
UPC / barcodes
7 66298 00318 47 66298 00317 7
Lot / date codes
  • All lots within expiry. AI Enzymes 120: 50048025 50058242 50063516 50067188 50076912 50080121 50092381 50092382 50104459 50108093 50114435 50118464 50125714 AI Enzymes 60: 50048027 50058243 50063517 50067189 50080122 50097606 50104460 50108094 50114436 50118465
Distribution area
NHAZCOOHNC

NH, AZ, CO, OH, NC

United States

Quantity affectedNot provided by the FDA.
Recall initiationFDA report date: December 6, 2017
FDA recall numberF-0397-2018

Beyond the headline

The recall, in context

Pure Encapsulations, INC. initiated this supplements recall on November 17, 2017. The FDA enforcement report states: Product contains undeclared sulfites. The FDA report lists distribution as: NH, AZ, CO, OH, NC.

The FDA enforcement report describes the reason as: Product contains undeclared sulfites.

Pure Encapsulations Ai Enzymes Dietary Supplement 120 Capsules was made or distributed by Pure Encapsulations, INC. in Sudbury, MA, United States. This page reflects FDA report F-0397-2018, dated December 6, 2017.

Why this is a Class III recall

Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. 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 is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.

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 Pure Encapsulations Ai Enzymes Dietary Supplement 120 Capsules recall?

Pure Encapsulations, INC. recalled Pure Encapsulations Ai Enzymes Dietary Supplement 120 Capsules in an FDA Class III enforcement action reported as F-0397-2018. Product contains undeclared sulfites.

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 Pure Encapsulations, INC. 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-0397-2018. 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

More recalls by Pure Encapsulations, INC.

View brand
Class III·

Pure Encapsulations, INC.

Pure Encapsulations Systemic Enzyme Complex Dietary Supplement 180 Capsules

Product contains undeclared sulfites.

NH, AZ, CO +2 moreSupplements

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