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Lower risk Food recall · FDA · Published November 17, 2017

Pure Encapsulations Enzyme Supplement Recall: Undeclared Sulfites in Dietary Supplement

Pure Encapsulations recalls 180-capsule enzyme supplement due to undeclared sulfites. Affected lots include 50074561 through 50129551. Consumers should check their product and contact the company for details.

🇺🇸 FDA recall #F-0396-2018FoodPure Encapsulations ›
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Contact the company

Recalling firmPure Encapsulations, Inc.490 Boston Post Rd · Sudbury, MA 01776-3367
✎ GovInfoNow plain-language explainer

What happened, in plain English

Pure Encapsulations is recalling their Systemic Enzyme Complex dietary supplement because it contains undeclared sulfites. This could cause allergic reactions in people sensitive to sulfites, which are common food preservatives. Read more at govinfonow.com/recall/20001-pure-encapsulations-enzyme-supplement-recall-undeclared-sulfites-in-dietary-supplement.

Source Summary by GovInfoNow · govinfonow.com/recall/20001-pure-encapsulations-enzyme-supplement-recall-undeclared-sulfites-in-dietary-supplement · Updated October 7, 2026 · FDA enforcement record: FDA #F-0396-2018

Cite this page

“Pure Encapsulations Enzyme Supplement Recall: Undeclared Sulfites in Dietary Supplement.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/20001-pure-encapsulations-enzyme-supplement-recall-undeclared-sulfites-in-dietary-supplement. Based on FDA recall #F-0396-2018 (https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-0396-2018%22&limit=1).

Why it’s dangerous

Sulfites are preservatives that can cause allergic reactions in sensitive individuals. The supplement contains sulfites without being declared on the label, which is a violation of food labeling regulations.

Who’s affected

People who own or use the Pure Encapsulations Systemic Enzyme Complex dietary supplement. Those with sulfite allergies are at higher risk of allergic reactions.

How to tell if you have this one

Check for the UPC 7 66298 00862 2 on the product label. The affected lots include 50074561, 50085867, 50102085, 50107811, 50113681, 50117860, 50121029, 50122279, 50123772, and 50129551.

  • Brand
    Pure Encapsulations
  • Product
    Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEMENT 180 CAPSULES UPC: 7 66298 00862 2
  • Category
    Food
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Terminated
  • Distribution
    NH, AZ, CO, OH, NC
Recall numberProduct, codes & lots
F-0396-2018Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEMENT 180 CAPSULES UPC: 7 66298 00862 2; All lots within expiry. Lot/Serial Number: 50074561 50085867 50102085 50107811 50113681 50117860 50121029 50122279 50123772 50129551
F-0397-2018pure encapsulations AI Enzymes DIETARY SUPPLEMENT 120 CAPSULES UPC: 7 66298 00318 4 and 60 CAPSULES UPC: 7 66298 00317 7; 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
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the UPC 7 66298 00862 2 and the affected lot numbers listed above.

Where it went and when

Where it was distributed

Distributed in 5 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: yesNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: yesOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: yesCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “NH, AZ, CO, OH, NC” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, Colorado, New Hampshire, North Carolina, Ohio.

Recall timeline

FDA terminated this recall 40 days after the firm started it.

1. Firm started the recall: Nov 17, 201712. FDA classified it Class III: Nov 29, 201723. Published in FDA’s Enforcement Report: Dec 6, 201734. FDA terminated the recall: Dec 27, 201742017
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #F-0396-2018 (November 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for F-0396-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA