Food Recall Check
Class II · Moderate risk Terminated Initiated Oct 6, 2021 (5 years ago)

Melatonin ER 5 mg caplet recall

Recalled by ULTRAtab Laboratories, Inc. · Highland, NY, United States

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

cGMP Deviations

These are failures of the safety steps that keep food safe - cooking, pasteurising, keeping cold, sealing - even when no contaminant has yet been found. All processing & sanitation problems recalls.

What was recalled

Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Quantity: 1,478,344 tablets

Food: Dietary supplements

Lot codes, dates and UPCs

A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.

Product Codes: M977A Bulk Lots: 19B011, 19B012, 19E023

Where it was sold

Florida New York

FDA's distribution note: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.

Check the codes, then return or discard. Class II means eating it may cause temporary or reversible health problems. If your package matches the recalled codes, do not eat it - return it to the store or throw it away. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.

Recalling firm
ULTRAtab Laboratories, Inc.
Initiated by
Voluntary: Firm initiated
Recall initiated
Oct 6, 2021
In FDA report of
Feb 16, 2022
Terminated
Sep 1, 2022
FDA recall number
F-0728-2022 · event 89512
Official record
FDA enforcement report search

Also recalled with it (8 more products)

FDA files each product of one recall action separately; these share the same FDA event.

Class II · Moderate risk Terminated Processing

Ephrine Plus Tablet

Reason cGMP Deviations

ULTRAtab Laboratories, Inc. FL, NY F-0721-2022