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.
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: 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
- Category
- Drug — Dietary Supplement
- Hazard
- 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
Related recalls
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateFDA Recalls Melatonin Tablets Due to Potential Labeling Errors
FDA (Drugs) · 2014-01-22
- ModerateAidapak Recalls Melatonin Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-22
- ModerateFDA Recalls Melatonin Tablets Due to Potential Label Mixup
FDA (Drugs) · 2014-01-22
- ModerateFDA Recalls Mislabeled Melatonin Tablets Distributed by Aidapak Services
FDA (Drugs) · 2014-01-22
- ModerateDrug recall: MidNite Sleep Health melatonin tablets, cGMP deviations
FDA (Drugs) · 2022-02-09
- ModerateMelatonin ER supplement recalled for manufacturing practice deviations
FDA (Food) · 2022-02-16