Lite Remfresh Melatonin Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling Lite Remfresh Advanced Ion-Powered Melatonin 0.5mg tablets nationwide due to cGMP (current good manufacturing practices) deviations. The recall affects 25,776 blisters in lots 19E058A and 19E058B with an expiration date of May 2022.
The agency’s classification
FDA (Drugs): 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 2/5 (Moderate).
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: This is an FDA Class II recall involving cGMP deviations, which are manufacturing/quality control issues. The source text does not report any illnesses, injuries, or deaths associated with the product, making it a precautionary recall without reported harm. Per the rubric, manufacturing deviations without reported adverse events typically warrant a Moderate severity score.
Plain-English summary
Ultra Seal Corporation is voluntarily recalling Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets sold in 36-count blisters. The recall was initiated on January 24, 2022, and classified by the FDA as a Class II recall on January 31, 2022.
The recall reason is cGMP (current good manufacturing practices) deviations identified during manufacturing. The affected product includes 25,776 blisters distributed nationwide within the United States under lot numbers 19E058A and 19E058B with an expiration date of May 2022.
Consumers who have purchased this product should stop using it. Affected units should be returned to the place of purchase or discarded. The recalling firm, Ultra Seal Corporation, initiated this recall voluntarily and the recall was terminated on October 16, 2023.
The recalled product
- Product
- Lite Remfresh Advanced Ion-Powered Melatonin (Melatonin 0.5mg) Tablets, 36-count blisters, Physician's Seal LLC, Boca Raton, FL 33487
- Manufacturer
- Ultra Seal Corporation
- Hazard
- Affected units
- 25,776
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 (3)
- Lot #: 19E058A
- 19E058B
- Exp. Date 05/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Ultra Seal Corporation under a single FDA (Drugs) 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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