Melatonin ER supplement recalled for manufacturing practice deviations
ULTRAtab Laboratories is voluntarily recalling approximately 955,928 melatonin ER 0.5 mg caplets due to deviations from FDA manufacturing standards. Bulk product distributed to New York and Florida distributors in 2021.
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 voluntary recall with no reported illnesses or injuries. The hazard involves manufacturing practice deviations without a specific contamination or injury risk explicitly identified, making this a precautionary quality assurance recall.
Plain-English summary
ULTRAtab Laboratories, Inc. is voluntarily recalling melatonin ER 0.5 mg caplets due to Current Good Manufacturing Practice (cGMP) deviations. The recall affects approximately 955,928 tablets manufactured under Product Code M975, Lot 19E058.
The company identified deviations from FDA manufacturing standards and initiated the voluntary recall to address manufacturing compliance concerns. The recall was initiated on October 6, 2021, and was officially terminated on September 1, 2022.
The bulk product was distributed to two distributors located in New York and Florida. These distributors may have repackaged and further distributed the finished product to retail outlets or other entities.
Consumers who have purchased this product should discontinue use and consult a healthcare provider if they have questions about their current melatonin therapy or potential alternatives.
The recalled product
- Product
- Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 955,928
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 (1)
- Product Codes: M975 Bulk Lots: 19E058
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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