Natrol, LLC Recall: One lot of ALA 300 mg Cap-50 were labeled at Melatonin 3 mg Tab-60. - F-0479-2021
United States
TerminatedClass II
- Company
- Natrol, LLC
- Product
- Natrol Melatonin 3 mg, Tab 60 White bottle with purple flip…
- Recall date
- April 8, 2021
- Terminated
- September 20, 2021
- Source
- FDA
Reason for recall
One lot of ALA 300 mg Cap-50 were labeled at Melatonin 3 mg Tab-60.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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 | Not published in this source record | 12,740 units | Lot 2084395, Expiration DEC31 23 |
Distribution
- AL
- AZ
- CA
- CO
- DE
- FL
- GA
- IA
- IL
- IN
- KY
- LA
- MA
- MD
- ME
- MI
- MN
- MO
- MS
- NC
- ND
- NJ
- NV
- NY
- OH
- OK
- OR
- PA
- PR
- TN
- TX
- UT
- VA
- WA
- WI
- WV and Ukraine
- Serbia
- Italy
- Trinidad
- Croatia
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-0479-2021
- Event ID
- 87704
- Status
- Terminated
- Classification
- Class II
- Company
- Natrol, LLC
- Product description
- 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
- Quantity
- 12,740 units
- Reason
- One lot of ALA 300 mg Cap-50 were labeled at Melatonin 3 mg Tab-60.
- Recall initiation date
- April 8, 2021
- Report date
- May 12, 2021
- Classification date
- Not published in this source record
- Termination date
- September 20, 2021
- Distribution pattern
- AL, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, TN, TX, UT, VA, WA, WI, WV and Ukraine, Serbia, Italy, Trinidad, Croatia
- UPC, lot, and code information
- Lot 2084395, Expiration DEC31 23
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Letter
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: Natrol, LLC
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| Alabama | 1 |
| Arizona | 1 |
| California | 1 |
| Colorado | 1 |
| Delaware | 1 |
| Florida | 1 |
| Georgia | 1 |
| Iowa | 1 |
| Illinois | 1 |
| Indiana | 1 |
| Kentucky | 1 |
| Louisiana | 1 |
| Massachusetts | 1 |
| Maryland | 1 |
| Maine | 1 |
| Michigan | 1 |
| Minnesota | 1 |
| Missouri | 1 |
| Mississippi | 1 |
| North Carolina | 1 |
| North Dakota | 1 |
| New Jersey | 1 |
| Nevada | 1 |
| New York | 1 |
| Ohio | 1 |
| Oklahoma | 1 |
| Oregon | 1 |
| Pennsylvania | 1 |
| Puerto Rico | 1 |
| Tennessee | 1 |
| Texas | 1 |
| Utah | 1 |
| Virginia | 1 |
| Washington | 1 |
| Wisconsin | 1 |
| West Virginia | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information. See FDA Enforcement Reports versus recall announcements for how that database differs from a press-release-style announcement.
New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
FDA classifies this recall as Class II. See how to read an FDA recall record (linked above) for what each classification level means.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the responsible agency's published instructions, linked below -- recall guidance is set by that agency, not by Public Health Trace.
Official guidance and record verification
Public Health Trace does not provide medical advice -- review the linked official source below for current, authoritative information.
How to interpret this historical record
This record is preserved as published by FDA, as of September 20, 2021.
Status as reported: Terminated.
This page does not imply a current danger or a current consumer instruction -- review the official source for the most current information.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.