The Recall Desk
ModerateFDA (Drugs)·D-0475-2022·Announced 2022-02-09

Drug recall: MidNite Sleep Health melatonin tablets, cGMP deviations

Ultra Seal Corporation is voluntarily recalling MidNite Sleep Health melatonin tablets nationwide due to current good manufacturing practice (cGMP) deviations. Approximately 2.2 million bottles are affected.

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. No reported illness, injury, or hospitalization is stated in the source text. Absent specific evidence of serious harm or a high-risk pathogen, this falls under a precautionary recall with manufacturing process concerns.

Plain-English summary

Ultra Seal Corporation is recalling MidNite Sleep Health melatonin tablets (1.5 mg) in 30-count bottles due to current good manufacturing practice (cGMP) deviations. The affected product was distributed nationwide across the United States.

Approximately 2,189,232 bottles are subject to this recall. Specific lot numbers include 18L124, 18L125, 18L126 (expiration date 02/2022); 19C037, 19C038, 19C039, 19C040 (expiration date 03/2022); 19D029, 19D030 (expiration date 04/2022); 19D031 (expiration date 06/2022); and 19G047 (expiration date 07/2022).

This is a voluntary recall initiated by the manufacturer. Consumers who have purchased affected product should stop use and contact Ultra Seal Corporation or the distributor, Mylan Consumer Healthcare, Inc., with questions.

The recalled product

Product
MidNite Sleep Health (melatonin 1.5 mg) tablets, 30-count bottles, Distributed by: Mylan Consumer Healthcare, Inc. Morgantown, WV 26505 USA
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 (16)

  • Lot #: 18L124
  • 18L125
  • 18L126
  • Exp. Date 02/2022
  • 19C037
  • 19C038
  • 19C039
  • 19C040
  • Exp. Date 03/2022
  • 19D029
  • 19D030
  • Exp. Date 04/2022
  • 19D031
  • Exp. Date 06/2022
  • 19G047
  • Exp. Date 07/2022

Distribution

Distributed nationwide across the United States.

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