Melatonin supplement MidNite Tablet recalled for manufacturing deviations

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

• manufacturing-quality

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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