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Class II Recall — Risk of Temporary or Reversible Adverse Health Consequences
Verified · FDAClass II — Possible RiskFood

ULTRAtab Laboratories, Inc. Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY Recall 2021

ULTRAtab Laboratories, Inc.Issued October 6, 2021

ULTRAtab Laboratories, Inc. Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY — recalled per FDA on 10/6/2021. Reason: cGMP Deviations.

Issuing agency
FDA
Issued
Oct 6, 2021
Brand
ULTRAtab Laboratories, Inc.
Distribution
2 states

What to do right now

  1. 1

    Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. 2

    Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. 3

    Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

  4. 4

    Clean prep surfaces

    Wash any utensils, cutting boards, or containers that touched the product with hot soapy water.

Verified source

U.S. Food and Drug Administration

Summary of the official FDA notice issued October 6, 2021. Last synced Apr 27, 2026. View on fda.gov

What's recalled

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

Why it was recalled

cGMP Deviations

Affected products & lot numbers
3 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Product Codes: M977A Bulk Lots: 19B011
19B012
19E023
Where was it sold
2 states

Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.

FLNY
View official FDA notice

View all questions for this recall →

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8 related — by brand, contaminant, and category

Frequently asked questions

Is the ULTRAtab Laboratories, Inc. recall still active?

Yes, this recall is currently active as of October 6, 2021. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Product Codes: M977A Bulk Lots: 19B011, 19B012, 19E023. Check the label on your product.

What should I do if I have the recalled ULTRAtab Laboratories, Inc.?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.