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ULTRAtab Laboratories, Inc.

FDA recall F-0726-2022 · Class II · reported 2022-02-16 · Terminated

Product
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Reason
cGMP Deviations
Quantity
955,928 tablets
Distribution
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Firm location
NY, United States
Initiated
Voluntary: Firm initiated
First notice
Letter
Recall started
2021-10-06
Terminated
2022-09-01
Code info
Product Codes: M975 Bulk Lots: 19E058

Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.

ULTRAtab Laboratories, Inc.: Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., | FoodFactsUSA