Severity
Moderate
ModerateClass IITerminated
FDA Food recall · Reported February 16, 2022
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
cGMP Deviations
ULTRAtab Laboratories, Inc. recalled Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY - a moderate-severity action.
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY was recalled by ULTRAtab Laboratories, Inc. in February 16, 2022. Reason: cGMP Deviations. Check the official notice for the remedy. Verify recall #F-0726-2022 with the FDA Food before acting.
The recall
ULTRAtab Laboratories, Inc. issued this moderate-severity FDA Food recall-cGMP Deviations.
- Moderate
- severity level
- Class II
- classification
- February 16, 2022
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-0726-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-0726-2022) was formally reported on February 16, 2022, with the manufacturer initiating the action on October 6, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. ULTRAtab Laboratories, Inc. is listed as the recalling firm, operating out of Highland, NY. Federal records list the affected scope as 955,928 tablets.
The documented reason for this recall is: cGMP Deviations Distribution data in the federal record shows the product reached: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Dietary Supplements recalls over time
Where this recall sits in its category - 2,002 dietary supplements recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
955,928 tablets
Related Recalls
6
6 from same agency
Product description
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Reason for recall
cGMP Deviations
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-0726-2022 |
| Date reported | February 16, 2022 |
| Date initiated | October 6, 2021 |
| Recalling firm | ULTRAtab Laboratories, Inc. |
| Firm location | Highland, NY |
| Affected scope | 955,928 tablets |
| Distribution | Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product. |
Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-0726-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Food before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY. Recalled by ULTRAtab Laboratories, Inc.. Units affected: 955,928 tablets.
Why was this product recalled? ▼
cGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Food on February 16, 2022. Severity: Moderate. Recall number: F-0726-2022.
Where was the recalled product distributed? ▼
Distribution: Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (F-0726-2022) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product? ▼
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported February 16, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.