Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Recalling firm: ULTRAtab Laboratories, Inc.
Why it was recalled
cGMP Deviations
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ProductMelatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
FDA code information
Product Codes: M977A Bulk Lots: 19B011, 19B012, 19E023
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Full FDA record and distribution details
Original product description
Melatonin ER 5 mg caplet (supplement), ULTRAtab Laboratories, Inc., Highland, NY
Recall details
- Recall number
- F-0728-2022
- Event ID
- 89512
- FDA status
- Terminated
- Initiated
- Oct 6, 2021
- Reported
- Feb 16, 2022
- Classified
- Feb 9, 2022
- Terminated
- Sep 1, 2022
- Quantity
- 1,478,344 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-0728-2022
Data updated September 16, 2026. View official FDA data ↗
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