CLASS II Food recall · Reported 20 Nov 2013 · FDA Enforcement Report
Serralase Enzyme Supplements recalled by ProThera
ProThera is recalling Serralase Enzyme Supplements. The recall was initiated on 10 Oct 2013 and the FDA has classified it as Class II.
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-0158-2014
- FDA event ID
- 66553
- Recalling firm
- ProThera, Reno, NV
- Brand
- Serralase Enzyme
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Oct 2013
- FDA classified
- 12 Nov 2013
- Reported
- 20 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Product category
- Dietary Supplements
Timeline
| 10 Oct 2013 | Recall initiated by company | |
| 12 Nov 2013 | Classified by FDA | +33 days |
| 20 Nov 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Serralase Enzyme Supplements; Packaged in 90 and 180 tablet bottled UPC - 90 count: 8 28054 00542 6 UPC- 180 count 8 28054 00149 7; Manufactured by: ProThera, Inc., Reno, NV 89521
Where it was distributed
US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.
Questions about this recall
Why was it recalled?
ProThera was notified by enzymes provided by Specialty Enzymes within the last 3-6 months may be contaminated with chloramphenicol.
Which lots are affected?
Lot F3994
Where was it sold?
US and Australia, Azerbaijan, Brazil, Canada, Germany, Great Britain, Hong Kong, Ireland (Eire, Japan, Malaysia, Malta, Mexico, New Zealand, Panama, Philippines, Russia, South Korea, Spain, Switzerland, Thailand.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 66553This product is part of a recall event; the main page for the event is Klaire Labs Interfase recalled by ProThera.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Klaire Labs Interfase recalled by ProTheraKlaire Labs | ProThera | Packaging Defects | NV | |
| CLASS II | Klaire Labs Vital-Zymes Chewable recalled by ProTheraKlaire Labs | ProThera | Other | NV | |
| CLASS II | Klaire Labs Interfase Plus recalled by ProTheraKlaire Labs | ProThera | Other | NV | |
| CLASS II | Klaire Labs Vital-Zymes complete recalled by ProTheraKlaire Labs | ProThera | Other | NV |
More recalls from ProThera
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|---|---|---|---|---|---|
| Food | CLASS II | Klaire Labs Reduced L-Glutathione, single capsule dose recalledKlaire Labs | ProThera | Packaging Defects | 14 states |
| Food | CLASS III | Klaire Labs Melatonin Lozenge Formula Fast Dissolving recalledKlaire Labs | ProThera | Other | KS |
| Food | CLASS II | Klaire Labs Ther-Biotic Factor 6 100+ Billion Cfu's recalled by ProTheraKlaire Labs | ProThera | Foreign Material | Nationwide |
| Food | CLASS II | Klaire Labs Ther-Biotic Children's Chewable 125+ Billion recalledKlaire Labs | ProThera | Foreign Material | Nationwide |
| Food | CLASS II | Pro Thera Dual Detox Dietary Supplement;; Chlorella recalledPro Thera | ProThera | Other | NV |
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