National Enzyme Recalls WellZymes Supplements Due to Chloramphenicol Contamination
National Enzyme Co is recalling specific WellZymes dietary supplements because they may contain chloramphenicol levels exceeding 0.3 ppb.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, which corresponds to a 'Severe' severity score under the provided rubric.
Plain-English summary
National Enzyme Co is voluntarily recalling two configurations of WellZymes dietary supplements: WellZymes Carbohydrate Digestion Enzyme Supplement (SKU 52644) and 6306 WellZymes CarboDigest U (SKU 54799). The recall involves 565 bottles from Lot #52644004 and Lot #54799000.
The recall was initiated because the products contain a raw material that may contain chloramphenicol at levels greater than 0.3 ppb. The FDA has classified this recall as Class II.
The affected products were distributed domestically in 27 states and internationally in Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom. Consumers should stop using the recalled products and contact the manufacturer for further instructions.
The recalled product
- Product
- Dietary Supplement packaged in the following configurations: (1) WELLZYMES, Carbohydrate Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52644). Manufactured exclusively for enzymes, inc., Parkville, MO.; (2) 6306 WellZymes CarboDigest U, packaged in…
- Manufacturer
- National Enzyme Co
- Category
- Food — Dietary Supplement
- Affected units
- 565
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #'s 52644004 and 54799000
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 81 recalled by National Enzyme Co under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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