Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Recall map → All recalls → F-0727-2022

Melatonin ER 2 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY ULTRAtab Laboratories, Inc. · reported 2022-02-16

Terminated This recall has been closed out by the agency.

Reason for recall: cGMP Deviations
Classification: Class II
Recall initiated: 2021-10-06
Reported by the agency: 2022-02-16
Closed out (terminated): 2022-09-01
Recalling firm: ULTRAtab Laboratories, Inc.
Highland, NY
United States
This is the firm that issued the recall — commonly a distributor or processor. It is not the origin of contamination.
Distribution (the agency's own words): Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
States we parsed from that text: FL NY
The agency named these states. Parse method explicit_state_list, confidence high.
Food category: Dietary supplementsderived
Assigned by a reviewed keyword rulebook over the product description, not by the agency.
Recall type: Voluntary: Firm initiated
Recall number: F-0727-2022

This page reproduces a record published by the US Food and Drug Administration. It is not real-time: recalls typically appear in FDA's Enforcement Report weeks after they begin — a median of 40 days, see publication lag. For current food safety information consult FDA and USDA FSIS directly.