Recall · openFDA Food Enforcement
Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories…: FDA Recall F-0727-2022 Agency action: Oct 6, 2021 Record ID: F-0727-2022
View official source ↗ What happened Original notice title
Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY, recall F-0727-2022
From the archived source record
cGMP Deviations
What the official notice says to do Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice → Status and source details
Status recorded in the archive Terminated
FDA recall classification Class II
Recall initiated by Voluntary: Firm initiated
Report date Feb 16, 2022
Termination date in the archive Sep 1, 2022
Source checked Jul 16, 2026
Record revision 721ab9b0a18f This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage → What is affected Product Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY Company ULTRAtab Laboratories, Inc. Lot / identifier Product Codes: M976 Bulk Lots: 19B050, 19F063 Market / distribution Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product. Quantity reported 5,853,539 tablets What is affected Product Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY Company ULTRAtab Laboratories, Inc. Lot / identifier Product Codes: M976 Bulk Lots: 19B050, 19F063 Market / distribution Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product. 