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ULTRAtab Laboratories, Inc.
FDA recall F-0728-2022 · Class II · reported 2022-02-16 · Terminated
- Product
- Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Reason
- cGMP Deviations
- Quantity
- 1,478,344 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: M977A Bulk Lots: 19B011, 19B012, 19E023
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.