FDAClass IIFebruary 16, 2022

MidNite Tablet recall: CGMP Deviations

MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY

Why was MidNite Tablet recalled?

cGMP Deviations

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Codes: M978 Bulk Lots: 18J069, 18J070, 18J071, 18M072, 18L124, 18L125, 18L126, 19C037, 19C038, 19C039, 19C040,19D029, 19D030, 19D031, 19G047, 19G048, 19G049, 19G050

Product
MidNite Tablet (Melatonin 1.5 mg) supplement, ULTRAtab Laboratories, Inc., Highland, NY
Recalling firm
ULTRAtab Laboratories, Inc.
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.
Recall date
February 16, 2022
Classification
Class II
Status
Terminated
Agency
FDA (food)
Open FDA enforcement record Latest FDA food recalls