Nutralox Peppermint Antacid Bulk Container Recalled for CGMP Deviations
ULTRAtab Laboratories, Inc. is recalling approximately 5.9 million tablets of Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) bulk container due to Current Good Manufacturing Practice (CGMP) deviations.
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 recall is FDA Class II, and the source text does not report any illness or injury. CGMP deviations represent a manufacturing deficiency with potential but unspecified harm, consistent with a precautionary recall classification.
Plain-English summary
ULTRAtab Laboratories, Inc. of Highland, New York is recalling Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) in bulk container form. The recall involves approximately 5,923,518 tablets with Product Codes M312 and Bulk Lots 18J004, 18J005, 18C045, and 19C046 (NDC 62959-312-00).
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. The bulk product was distributed to 3 distributors who may have distributed finished products to customers.
This is a voluntary recall initiated by the manufacturer on January 26, 2022, and was classified as FDA Class II on February 9, 2022. The recall was terminated on January 7, 2025. Consumers who have purchased this product should consult with their healthcare provider or pharmacist if they have questions about their use of this antacid.
The recalled product
- Product
- Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-312-00
- Manufacturer
- ULTRAtab Laboratories, Inc.
- Category
- Drug — Antacid
- Affected units
- 5,923,518
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 Codes: M312 Bulk Lots: 18J004
- 18J005
- 18C045
- 19C046
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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