Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
Recalling firm: ULTRAtab Laboratories, Inc.
Why it was recalled
cGMP Deviations
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ProductElectrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
FDA code information
Product Codes: M693 Bulk Lots: 18J001, 18J002, 18J003, 18L035, 18L036, 18M013, 18M014, 19A044, 19A045, 19B042, 19B043, 19B066, 19C006, 19C007, 19E065, 19E066, 19J045, 19J046
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Full FDA record and distribution details
Original product description
Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
Recall details
- Recall number
- F-0722-2022
- Event ID
- 89512
- FDA status
- Terminated
- Initiated
- Oct 6, 2021
- Reported
- Feb 16, 2022
- Classified
- Feb 9, 2022
- Terminated
- Sep 1, 2022
- Quantity
- 26,682,419 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-0722-2022
Data updated September 16, 2026. View official FDA data ↗
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