Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Recalling firm: ULTRAtab Laboratories, Inc.
Why it was recalled
cGMP Deviations
The exact product
Melatonin ER 0.5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Check the codes
Compare these FDA-provided codes, lot numbers or dates with the product you have.
Match the product, size and code together. A similar name alone does not identify your batch.
Original FDA code information
Product Codes: M975 Bulk Lots: 19E058
Recall details
- Recall number
- F-0726-2022
- Event ID
- 89512
- FDA status
- Terminated
- Initiated
- Oct 6, 2021
- Reported
- Feb 16, 2022
- Classified
- Feb 9, 2022
- Terminated
- Sep 1, 2022
- Quantity
- 955,928 tablets
- Location
- Highland, NY, United States
- Initiation type
- Voluntary: Firm initiated
- Notification
- Letter
Where it was distributed
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.
FDA source record · F-0726-2022
Data updated September 16, 2026. View official FDA data ↗
A missing code match is not a guarantee of safety. Follow official FDA and manufacturer guidance.