OTC Antacid Tablets Recalled for Failed Disintegration Specification
Sato Pharmaceutical Co., Ltd. is recalling INON ACE antacid tablets (3,640 bottles, Lot PWXT) distributed in California and Hawaii because the tablets fail to disintegrate according to specification. No illnesses have been reported.
What this means for you
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 recall with no reported illnesses or injuries. The hazard is a failed disintegration specification—a quality and efficacy issue rather than a direct safety threat. Per the rubric, recalls with no reported harm and theoretical hazards involving quality defects fall under Moderate severity.
Plain-English summary
Sato Pharmaceutical Co., Ltd. is recalling INON ACE antacid tablets distributed in California and Hawaii. The recalled product consists of 3,640 bottles containing 75-count tablets with the lot number PWXT and expiration date of January 31, 2027. The tablets contain magnesium aluminosilicate, magnesium hydroxide, and simethicone.
The tablets have failed to meet disintegration specifications. Tablets that do not disintegrate properly in the digestive tract may not work as intended.
Consumers who have purchased INON ACE antacid tablets with lot number PWXT should stop using the product and contact Sato Pharmaceutical Co., Ltd. if they have questions or concerns about their purchase. Healthcare providers can also be consulted if there are any medical concerns.
The recalled product
- Product
- INON ACE (MAGNESIUM ALUMINOSILICATES, MAGNESIUM HYDROXIDE, SIMETHICONE)
- Brand
- INON ACE
- Manufacturer
- Sato Pharmaceutical Co., Ltd
- Category
- Drug — Antacid
- Hazard
- failed-disintegration
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 (2)
- Lot#: PWXT
- Exp 1/31/2027
UPCs (1)
- 0349873402017
Distribution
Distributed in 2 states:
- CA
- HI
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