Sato Pharmaceutical Inc.

Complete recall history across all FDA and CPSC categories — 8 total recalls

Sato Pharmaceutical Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (8)

FDA drug safety enforcement actions by Sato Pharmaceutical Inc.

Date Product Reason Class
Oct 1, 2019 Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distribute... Subpotent Drug Class III
Oct 1, 2019 WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (... Subpotent Drug Class III
Oct 1, 2019 Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, D... Subpotent Drug Class III
Oct 1, 2019 Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) ... Subpotent Drug: Formulated amount of sennosides component is less than labell... Class III
Oct 1, 2019 Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distri... Subpotent Drug Class III
Feb 16, 2017 SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged i... Lack of Assurance of Sterility: Firm failed to establish an adequate system f... Class II
Feb 16, 2017 DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL)... Lack of Assurance of Sterility: Firm failed to establish an adequate system f... Class II
Feb 16, 2017 Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15... Lack of Assurance of Sterility: Firm failed to establish an adequate system f... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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