Electrolyte Tablets Recalled by ULTRAtab Laboratories Due to Manufacturing Deviations
ULTRAtab Laboratories has recalled approximately 26.6 million electrolyte tablets due to manufacturing practice deviations. The bulk product was distributed to distributors in New York and Florida.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II voluntary precautionary recall with no reported illnesses or injuries. The hazard is identified as cGMP deviations (manufacturing practice violations) without a specific named contamination or defect.
Plain-English summary
ULTRAtab Laboratories, Inc. is recalling approximately 26.6 million electrolyte tablets due to Current Good Manufacturing Practice (cGMP) deviations. The tablets contain calcium 10.8 mg, potassium 40 mg, and magnesium 12 mg per tablet.
The recalled bulk product was distributed to 2 distributors located in New York and Florida. These distributors may have repackaged and further distributed the finished product to retailers and consumers.
This is a Class II recall initiated on October 6, 2021, and was terminated on September 1, 2022. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Electrolyte tablet (Calcium 10.8mg, Potassium 40mg, Magnesium 12 mg), ULTRAtab Laboratories, Inc., Highland, NY
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Hazard
- Affected units
- 26,682,419
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 (18)
- Product Codes: M693 Bulk Lots: 18J001
- 18J002
- 18J003
- 18L035
- 18L036
- 18M013
- 18M014
- 19A044
- 19A045
- 19B042
- 19B043
- 19B066
- 19C006
- 19C007
- 19E065
- 19E066
- 19J045
- 19J046
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.
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