The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Food)·F-0729-2022·Announced 2022-02-16

Melatonin supplement MidNite Tablet recalled for manufacturing deviations

ULTRAtab Laboratories voluntarily recalled MidNite Tablet melatonin supplements due to manufacturing practice deviations. The recall encompasses 42,352,387 tablets distributed in bulk to two distributors in New York and Florida.

The agency’s classification

FDA (Food): 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 for manufacturing practice deviations with no reported illnesses, injuries, or deaths. Per the severity rubric, Class II recalls without hospitalization reports and with theoretical hazards are classified as Moderate.

Plain-English summary

ULTRAtab Laboratories, Inc., of Highland, New York, voluntarily recalled MidNite Tablet melatonin supplements (1.5 mg) due to manufacturing practice deviations. The recall encompasses 42,352,387 tablets bearing Product Code M978 and specified bulk lot numbers.

The reason for the recall was identified as Current Good Manufacturing Practice (cGMP) deviations—violations of manufacturing quality standards required by the Food and Drug Administration. The deviations were found in the manufacturer's production process.

The affected bulk product was distributed to two distributors in New York and Florida, which may have repackaged and distributed the finished product to retail customers. The extent of finished product distribution to consumer-facing retailers depends on the repackaging activities by these distributors.

The FDA classified this as a Class II recall. Consumers should verify their product code and lot numbers against the recall information if they have this product. This recall was initiated on October 6, 2021, and was administratively terminated on September 1, 2022.

The recalled product

Product
MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Food — Dietary Supplement
Hazard
Affected units
42,352,387

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 (18)

  • Product Codes: M978 Bulk Lots: 18J069
  • 18J070
  • 18J071
  • 18M072
  • 18L124
  • 18L125
  • 18L126
  • 19C037
  • 19C038
  • 19C039
  • 19C040
  • 19D029
  • 19D030
  • 19D031
  • 19G047
  • 19G048
  • 19G049
  • 19G050

Distribution

Distributed in 2 states:

Part of a larger recall action

This product is one of 9 recalled by ULTRAtab Laboratories, Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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