Hepatodoron® Dietary Supplement Tablets Recalled for Potential Metal Contamination
Weleda Inc is recalling Hepatodoron® tablets due to potential metal contamination. The affected batch (J033, expiring January 31, 2027) was distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with a risk-of-harm hazard (metal contamination in an ingested product) where no illnesses or injuries have yet been reported. The potential for injury from ingesting metal contamination justifies a High severity rating.
Plain-English summary
Weleda Inc is recalling Hepatodoron® tablets (200-piece packages) due to potential metal contamination. This is a Class II FDA recall affecting 890 units distributed nationwide.
The affected batch is Batch No. J033 with an expiration date of January 31, 2027. No illnesses or injuries related to this product have been reported.
Consumers who have purchased Hepatodoron® tablets from the affected batch should stop using the product immediately. If you have questions or concerns, contact Weleda Inc or visit the FDA's recall information page.
The recalled product
- Product
- Hepatodoron¿ tablets, 200 pcs
- Manufacturer
- Weleda Inc
- Category
- Drug — Dietary Supplement
- Hazard
- Affected units
- 890
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 (2)
- Art.-No. 00326500/003265xx Batch no: J033 Expiry date: January 31
- 2027
Distribution
Distributed nationwide across the United States.
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