CLASS III Food recall · Reported 6 Dec 2017 · FDA Enforcement Report
Systemic Enzyme Complex Dietary Supplement recalled
Pure Encapsulations is recalling Pure Encapsulations Systemic Enzyme Complex Dietary Supplement, distributed in Arizona, Colorado, North Carolina, New Hampshire, Ohio. The recall was initiated on 17 Nov 2017 and the FDA has classified it as Class III.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-0396-2018
- FDA event ID
- 78589
- Recalling firm
- Pure Encapsulations, Sudbury, MA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Nov 2017
- FDA classified
- 29 Nov 2017
- Reported
- 6 Dec 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Undeclared Sulfites
- Product category
- Dietary Supplements
Timeline
| 17 Nov 2017 | Recall initiated by company | |
| 29 Nov 2017 | Classified by FDA | +12 days |
| 6 Dec 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product contains undeclared sulfites.
Product as listed by the FDA
Pure Encapsulations Systemic Enzyme Complex DIETARY SUPPLEMENT 180 CAPSULES UPC: 7 66298 00862 2
Where it was distributed
NH, AZ, CO, OH, NC
Questions about this recall
Is Systemic Enzyme Complex Dietary Supplement recalled?
Yes. Pure Encapsulations recalled Systemic Enzyme Complex Dietary Supplement on 17 Nov 2017. The recall is Class III and its status is Terminated. Recall number F-0396-2018.
Why was it recalled?
Product contains undeclared sulfites.
Which lots are affected?
All lots within expiry. Lot/Serial Number: 50074561 50085867 50102085 50107811 50113681 50117860 50121029 50122279 50123772 50129551
Where was it sold?
NH, AZ, CO, OH, NC
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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