The Recall Desk
ModerateFDA (Food)·F-0727-2022·Announced 2022-02-16

Dietary supplement melatonin recall due to manufacturing deviations

ULTRAtab Laboratories is recalling melatonin ER 2 mg caplets due to manufacturing process deviations. The recall affects 5.8 million tablets distributed to wholesalers.

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 for manufacturing process deviations with no reported illnesses or injuries, consistent with a voluntary precautionary recall.

Plain-English summary

ULTRAtab Laboratories, Inc. is recalling melatonin ER 2 mg caplets due to manufacturing process deviations. The recall was initiated on October 6, 2021, and terminated on September 1, 2022.

The affected product was distributed in bulk form to two distributors located in New York and Florida, who may have repackaged it for further distribution. The total quantity recalled is 5,853,539 tablets with product codes M976 and bulk lot numbers 19B050 and 19F063.

Consumers who have purchased this product should stop using it. Questions or concerns should be directed to a healthcare provider or the manufacturer.

The recalled product

Product
Melatonin ER 2 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 (2)

  • Product Codes: M976 Bulk Lots: 19B050
  • 19F063

Distribution

Distributed in 2 states:

  • FL
  • NY

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