Peppermint Antacid Tablets Recalled for CGMP Deviations
ULTRAtab Laboratories is recalling Peppermint Antacid tablets (Calcium Carbonate 420 mg) in bulk containers due to current good manufacturing practice (CGMP) deviations. The recall was initiated voluntarily by the manufacturer.
The agency’s classification
FDA (Drugs): 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: The FDA classified this as a Class II recall, and the source text does not report any illnesses, injuries, or deaths. CGMP deviations represent a manufacturing quality issue rather than a confirmed hazard to consumers. Per the rubric, Class II recalls without reported hospitalization or significant injury are typically Moderate.
Plain-English summary
ULTRAtab Laboratories, Inc., located in Highland, New York, is recalling approximately 3.3 million Peppermint Antacid tablets (Calcium Carbonate 420 mg) in bulk containers. The product is identified as NDC 62959-303-00, with Product Code M303 (bulk lots 19C042, 19C043, 19F083) and Product Code M303A (bulk lot 19E105).
The recall was issued because the bulk product did not meet current good manufacturing practice (CGMP) standards. The bulk product was distributed to three distributors, who may have distributed the finished product to other entities.
The manufacturer initiated this recall voluntarily on January 26, 2022. The FDA classified this as a Class II recall on February 9, 2022. The recall was terminated on January 7, 2025. Consumers who have this product should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Peppermint Antacid tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-303-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Hazard
- Affected units
- 3,349,387
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 (4)
- Product Code: M303 Bulk lots: 19C042
- 19C043
- 19F083
- Product Code: M303A Bulk Lot: 19E105
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 33 recalled by ULTRAtab Laboratories, Inc. under a single FDA (Drugs) 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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