The Recall Desk
ModerateFDA (Food)·F-0728-2022·Announced 2022-02-16

Melatonin ER supplement recalled for manufacturing practice deviations

ULTRAtab Laboratories voluntarily recalled Melatonin ER 5 mg caplets due to manufacturing deviations. The bulk product distributed to wholesalers in New York and Florida may have been repackaged and resold.

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: FDA Class II recall with no reported illnesses, injuries, or specific hazard identified. The recall addresses manufacturing process deviations and was voluntarily initiated by the firm as a precautionary measure.

Plain-English summary

ULTRAtab Laboratories, Inc. of Highland, New York recalled Melatonin ER 5 mg caplets due to deviations from FDA Current Good Manufacturing Practice (cGMP) standards during the manufacturing process.

Approximately 1,478,344 tablets in bulk form were distributed to two distributors in New York and Florida. These distributors may have repackaged the bulk product and distributed finished goods to retail. The recall was initiated on October 6, 2021, and was completed on September 1, 2022. The firm voluntarily initiated this recall.

The recall addresses manufacturing process compliance issues identified by the firm.

The recalled product

Product
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Manufacturer
ULTRAtab Laboratories, Inc.
Category
Food — Dietary Supplement
Hazard
  • manufacturing-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 (3)

  • Product Codes: M977A Bulk Lots: 19B011
  • 19B012
  • 19E023

Distribution

Distributed in 2 states:

  • FL
  • NY

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