Melatonin ER supplement recalled for manufacturing practice deviations
ULTRAtab Laboratories voluntarily recalled Melatonin ER 5 mg caplets due to manufacturing deviations. The bulk product distributed to wholesalers in New York and Florida may have been repackaged and resold.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or specific hazard identified. The recall addresses manufacturing process deviations and was voluntarily initiated by the firm as a precautionary measure.
Plain-English summary
ULTRAtab Laboratories, Inc. of Highland, New York recalled Melatonin ER 5 mg caplets due to deviations from FDA Current Good Manufacturing Practice (cGMP) standards during the manufacturing process.
Approximately 1,478,344 tablets in bulk form were distributed to two distributors in New York and Florida. These distributors may have repackaged the bulk product and distributed finished goods to retail. The recall was initiated on October 6, 2021, and was completed on September 1, 2022. The firm voluntarily initiated this recall.
The recall addresses manufacturing process compliance issues identified by the firm.
The recalled product
- Product
- Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Food — Dietary Supplement
- Hazard
- Affected units
- 1,478,344
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product Codes: M977A Bulk Lots: 19B011
- 19B012
- 19E023
Distribution
Part of a larger recall action
This product is one of 9 recalled by ULTRAtab Laboratories, Inc. under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · ULTRAtab Laboratories, Inc.
See all →- ModerateDBI Magnums Caffeine Tablets Recalled for CGMP Deviations
FDA (Drugs) · 2022-02-16
- ModerateHPC Tablet Drug Recalled Due to CGMP Manufacturing Deviations
FDA (Drugs) · 2022-02-16
- ModerateDietary supplement melatonin recall due to manufacturing deviations
FDA (Food) · 2022-02-16
- Moderate
- ModerateCaffeine dietary supplement recalled due to manufacturing practice deviations
FDA (Food) · 2022-02-16
Same hazard · manufacturing deviation
See all →- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateiVIZIA Dry Eye Lubricant Drops Recalled for Sterility Assurance
FDA (Drugs) · 2026-05-06