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ULTRAtab Laboratories, Inc.
FDA recall F-0729-2022 · Class II · reported 2022-02-16 · Terminated
- Product
- MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
- Reason
- cGMP Deviations
- Quantity
- 42,352,387 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: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050
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.