Zinc Sulfate Monohydrate ingredient recalled for potential lead contamination
Jost Chemical Co is recalling Zinc Sulfate Monohydrate, USP, because it may contain elevated levels of lead. This pharmaceutical ingredient was distributed to multiple countries including the United States.
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 classification with lead contamination, a serious health hazard. No illnesses or injuries have been reported, making this a high-risk but not-yet-materialized hazard.
Plain-English summary
Jost Chemical Co is recalling a chemical ingredient called Zinc Sulfate Monohydrate, USP. The product comes in 55-pound (25-kilogram) bags and is intended for use in manufacturing, processing, and repacking.
The FDA initiated this recall (Class II) because the ingredient may contain elevated levels of lead. Lead is a toxic substance that poses serious health risks, particularly to developing children and pregnant women.
The recall affects a total of 9,680 pounds of the product. It was distributed to Canada, Chile, Indonesia, Israel, and several U.S. states (Arizona, California, Iowa, and Utah). The affected lot number is 29892013.
Manufacturers and processors who received this ingredient should stop using it and contact Jost Chemical Co. While no illnesses have been reported to date, anyone who believes they may have been exposed to this product should consult a healthcare provider.
The recalled product
- Product
- Zinc Sulfate Monohydrate, USP, Powder. Net Wt: 55 lb / 25 kg. Jost Chemical 8150 Lackland, St. Louis, MO 63114. Caution: For Manufacturing, Processing, or Repacking.
- Manufacturer
- Jost Chemical Co
- Category
- Drug — Pharmaceutical Ingredient
- Hazard
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 29892013
Distribution
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