MidNite Natural Sleep Aid Chewable Tablets Recalled for cGMP Deviations
Ultra Seal Corporation is recalling MidNite Natural sleep aid chewable tablets nationwide due to current good manufacturing practice (cGMP) deviations. The recall affects 90,072 bottles distributed across the United States.
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 initiated voluntarily by the firm for cGMP deviations (manufacturing process violations). The source text does not report any illnesses, injuries, or hospitalizations, making this a precautionary recall based on manufacturing control deficiencies rather than an actual product hazard.
Plain-English summary
Ultra Seal Corporation is recalling MidNite Natural sleep aid chewable tablets (melatonin 1.5mg) in cherry flavor, 30-count bottles, due to current good manufacturing practice (cGMP) deviations. The affected product was distributed nationwide within the United States.
The recall involves 90,072 bottles across three lots: Lot #19C038C (expiration date 03/2022), Lot #19G047C (expiration date 07/2022), and Lot #18L124C (expiration date 02/2022). The manufacturer, Ultra Seal Corporation, initiated this voluntary recall on January 24, 2022, which was terminated on October 16, 2023.
The FDA classified this as a Class II recall based on the cGMP deviations identified in the manufacturing process. Consumers who have purchased affected products are advised to stop using them and consult with a healthcare provider if they have any health concerns.
The recalled product
- Product
- MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6
- Manufacturer
- Ultra Seal Corporation
- Category
- Drug — Sleep Aid / Supplement
- Hazard
- Affected units
- 90,072
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 (6)
- Lot #: 19C038C
- Exp. Date 03/2022
- 19G047C
- Exp. Date 07/2022
- 18L124C
- Exp. Date 02/2022
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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