The Recall Desk
ModerateFDA (Drugs)·D-0506-2022·Announced 2022-02-09

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.

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 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
Hazard
  • cgmp-deviation

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.