Electrolyte Supplement Tablets Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling approximately 1.47 million packets of Electrolyte Supplement Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations identified during manufacturing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as Class II, and the source text states no illnesses or injuries have been reported. The hazard is a manufacturing deviation rather than a direct safety threat with confirmed harm. This falls under the Moderate category for FDA Class II recalls without reported hospitalization or illness.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Electrolyte Supplement Tablets containing calcium 5.2 mg, potassium 20.8 mg, and magnesium 6 mg in 2-count packets. The recall affects approximately 1,474,050 packets distributed nationwide within the United States. The affected lot numbers are AK9797 and AK9254.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. The firm notified the FDA by letter, and the recall was classified as Class II on January 31, 2022. The recall was initiated on January 24, 2022, and was terminated on October 16, 2023.
Consumers who have purchased this product should discontinue use and contact the recalling firm or their healthcare provider with questions.
The recalled product
- Product
- ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Dietary Supplement
- Hazard
- cGMP-deviation
- manufacturing-defect
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)
- Lot #: AK9797
- AK9254
Distribution
Distributed nationwide across the United States.
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