Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0540-2022·Announced 2022-02-16

Cherry Antacid Tablets Recalled for CGMP Deviations

ULTRAtab Laboratories is recalling Cherry Antacid Tablets (Calcium Carbonate 420 mg) in bulk containers due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall.

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 for CGMP deviations. The source text does not report any illnesses, injuries, or confirmed product quality failures—only manufacturing process violations. This qualifies as a moderate-severity precautionary recall.

Plain-English summary

ULTRAtab Laboratories, Inc., located in Highland, New York, is voluntarily recalling Cherry Antacid Tablets (Calcium Carbonate 420 mg) distributed in bulk containers. The recall affects approximately 3,052,313 tablets with product code M304 and bulk lots 18K059, 18L106, 18L117, 18M067, and 18M068 (NDC 62959-304-00).

The recall was initiated because the manufacturer identified Current Good Manufacturing Practice (CGMP) deviations during production. The FDA classified this as a Class II recall on February 9, 2022, and the firm voluntarily initiated the recall on January 26, 2022.

The bulk product was distributed to three distributors, who may have further distributed finished products. Consumers who have purchased these antacid tablets should stop using the product. Healthcare providers and distributors who received this product should contact their suppliers for instructions on return or disposal. The recall was terminated on January 7, 2025.

The recalled product

Product: Cherry Antacid Tablet (Calcium Carbonate 420 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-304-00
Manufacturer: ULTRAtab Laboratories, Inc.
Category: Drug — Antacid / Over-the-Counter
Hazard: cgmp-deviation
Affected units: 3,052,313

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 (5)

Product Codes: M304 Bulk Lots: 18K059
18L106
18L117
18M067
18M068

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.

See all 33 products in this recall →

Same manufacturer · ULTRAtab Laboratories, Inc.

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