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.
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: 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
- Affected units
- 5,853,539
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
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.
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