The Recall Desk
ModerateFDA (Food)·F-0479-2021·Announced 2021-05-12

Natrol Melatonin 3 mg Tablets Recalled for Mislabeling as ALA 300 mg

Natrol LLC is recalling one lot of Melatonin 3 mg tablets that were mislabeled as ALA 300 mg capsules. The recall covers 12,740 units distributed across multiple US states and international locations.

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: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Natrol LLC is recalling one lot of Natrol Melatonin 3 mg tablets (60-count bottles) that were incorrectly labeled as ALA 300 mg capsules (50-count). The affected product is Lot 2084395 with an expiration date of December 31, 2023. The mislabeling involves a discrepancy between the product identity and dosage form indicated on the packaging.

A total of 12,740 units were distributed in the United States (including Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia) and internationally (Ukraine, Serbia, Italy, Trinidad, and Croatia).

Consumers with this specific lot of Natrol Melatonin 3 mg tablets should stop using the product and contact Natrol LLC for a refund or further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Natrol Melatonin 3 mg, Tab 60 White bottle with purple flip-top cap. Fall asleep faster, Stay asleep longer, 100$ Drug Free 1 Tablet 20 minutes before bedtime. Manufactured by Natrol LLC. Chatsworth, CA 91311 USA
Manufacturer
Natrol, LLC
Affected units
12,740

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)

  • Lot 2084395
  • Expiration DEC31 23

Distribution