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Medium RiskFDA Food
Medications & Supplements/Dietary Supplements

Natrol, LLC: Natrol Melatonin 3 mg Recalled Due to Incorrect Labeling and Ingredient Mix-up

Agency Publication Date: May 6, 2021
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Summary

Natrol, LLC is recalling one lot (totaling 12,740 units) of Natrol Melatonin 3 mg, 60-count tablets because the bottles may actually contain ALA (Alpha Lipoic Acid) 300 mg capsules. The affected product is packaged in a white bottle with a purple flip-top cap and was distributed across 35 states and several international locations. Consumers who purchased this specific lot should stop using the product immediately as it contains an ingredient other than what is listed on the label.

Risk

The product is mislabeled and contains Alpha Lipoic Acid (ALA) instead of Melatonin, which can lead to consumers taking an unintended substance or dosage. This poses a health risk to individuals who may have sensitivities to ALA or who are relying on the specific effects of Melatonin.

What You Should Do

  1. Check your bottle of Natrol Melatonin 3 mg (60 Tablets) for Lot Number 2084395 and an Expiration Date of DEC31 23.
  2. Verify the physical contents: the recalled product is a capsule (ALA 300 mg) but is labeled as a tablet (Melatonin 3 mg).
  3. Stop using the product immediately if it matches the affected lot number.
  4. Contact your healthcare provider or pharmacist for guidance regarding the consumption of Alpha Lipoic Acid if you have already taken the product.
  5. Return any unused product to the place of purchase for a full refund or contact Natrol, LLC for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Product refund or pharmacist consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.

Affected Products

Product: Natrol Melatonin 3 mg (60 Tablets)
Lot Numbers:
2084395 (Exp DEC31 23)
Date Ranges: Expiration DEC31 23

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87704
Status: Resolved
Manufacturer: Natrol, LLC
Manufactured In: United States
Units Affected: 12,740 units
Distributed To: 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, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.