CLASS II Food recall · Reported 16 Feb 2022 · FDA Enforcement Report
Melatonin ER 5 mg caplet (supplement) recalled by ULTRAtab Laboratories
ULTRAtab Laboratories is recalling Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY, distributed in Florida, New York. The recall was initiated on 6 Oct 2021 and the FDA has classified it as Class II.
Check your package
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
Recall details
- Recall number
- F-0726-2022
- FDA event ID
- 89512
- Recalling firm
- ULTRAtab Laboratories, Highland, NY
- Brand
- Melatonin ER
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Oct 2021
- FDA classified
- 9 Feb 2022
- Reported
- 16 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Product category
- Dietary Supplements
Timeline
| 6 Oct 2021 | Recall initiated by company | |
| 9 Feb 2022 | Classified by FDA | +126 days |
| 16 Feb 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations
Product as listed by the FDA
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Where it was distributed
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
Questions about this recall
Is Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY recalled?
Yes. ULTRAtab Laboratories recalled Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY on 6 Oct 2021. The recall is Class II and its status is Terminated. Recall number F-0726-2022.
Why was it recalled?
cGMP Deviations
Which lots are affected?
Product Codes: M975 Bulk Lots: 19E058
Where was it sold?
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
What should I do if I have it?
Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ULTRAtab Laboratories
All 43Other Dietary Supplements recalls
All 733| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | ANNOUNCED | Niwali Tejocote Capsules and Pieces recalled by Global MixNiwali | Global Mix | Foreign Material | Nationwide |
| Food | CLASS I | Addall XR Shot, liquid dietary supplement recalled by ZMB EnterprisesAddall XR | ZMB Enterprises | Hidden Drug Ingredients | CA |
| Food | CLASS II | Super Skin; Dietary Supplement;, 2 per day recalled by Mellish IslandMellish Island | Mellish Island | Other | Nationwide |
| Food | CLASS I | Modern Warrior Ready, Dietary Supplement recalledModern Warrior | Modern Warrior Life | Hidden Drug Ingredients | Nationwide |
| Food | CLASS II | Vista MAX; Dietary Supplement Serving Size recalled by Provision HealthVista MAX | Provision Health | Undeclared Allergens | CA |