REMfresh Melatonin Caplets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling REMfresh Advanced Ion-Powered Melatonin 5 mg caplets nationwide due to cGMP (current good manufacturing practice) deviations. The recall affects approximately 40,344 blisters of the product.
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: This is an FDA Class II recall with no reported illnesses or injuries. cGMP deviations are manufacturing compliance issues that do not directly indicate a specific safety hazard to consumers. The recall appears to be precautionary in nature, consistent with a Moderate severity classification.
Plain-English summary
Ultra Seal Corporation is recalling REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets packaged in 36-count blisters due to cGMP deviations identified during manufacturing. The affected lots are 19B011, 19B012, 19B012A, and 19E023, with an expiration date of 05/2022. Approximately 40,344 blisters were distributed nationwide within the United States.
The recall was initiated on January 24, 2022, and is classified as a Class II recall. The firm voluntarily initiated this recall after the FDA notified them of the manufacturing deviations. Consumers who have purchased this product should stop using it and contact the manufacturer or their healthcare provider with questions.
The recalled product
- Product
- REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
- Manufacturer
- Ultra Seal Corporation
- Hazard
- cgmp-deviation
- manufacturing-compliance
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 (5)
- Lot #: 19B011
- 19B012
- 19B012A
- 19E023
- Exp. Date 05/2022
Distribution
Distributed nationwide across the United States.
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