Empirical Labs Recalls Digesti-Zyme Supplements Due to Chloramphenicol Contamination
Empirical Labs is recalling specific lots of Digesti-Zyme dietary supplements because they may be contaminated with chloramphenicol.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for serious adverse health consequences (such as contamination with a prohibited drug like chloramphenicol) are classified as Severe (Score 4), especially when no specific hospitalization reports are cited to lower it to High, but the risk is significant enough to warrant a high severity rating under the 'never go below 4' rule for Class I/II contexts where harm is plausible.
Plain-English summary
Empirical Labs is voluntarily recalling certain lots of its Building Health Digesti-Zyme dietary supplements. The recall was initiated due to the potential for adulteration with chloramphenicol, a substance that is not permitted in dietary supplements.
The affected product consists of 180-capsule bottles of Digesti-Zyme. The specific lot number involved in this recall is 3080101. A total of 246 units were distributed. The products were shipped to Idaho, Minnesota, and South Carolina, as well as to Sweden. There were no military, government, or VA consignees.
Consumers who have purchased this specific lot of Digesti-Zyme should stop using the product and contact the manufacturer for further instructions or a refund. The recall is classified as Class II by the FDA, indicating a remote probability of serious adverse health consequences or temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Empirical Labs Building Health Digesti-Zyme; 180 Capsules Dietary SupplementSupplement
- Manufacturer
- Empirical Laboratories, Incorporated
- Category
- Food — Dietary Supplement
- Affected units
- 246
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)
- Lots: 3080101
Distribution
Part of a larger recall action
This product is one of 13 recalled by Empirical Laboratories, Incorporated 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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