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Sato Pharmaceutical Inc.

FDA Regulatory Profile

Sato Pharmaceutical Inc. has 10 FDA recalls, 9 inspections, 0 510(k) clearances and 2 compliance actions on record.

What these totals cover: FDA records filed under the name "Sato Pharmaceutical Inc." and its spelling variants "Sato Pharmaceutical", "Sato Pharmaceutical Co".

Latest recall: H-0892-2026 · Class III · Mar 12, 2026
Latest inspection: Nov 21, 2025 · OAI

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Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	10	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	9	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Sato Pharmaceutical Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Year	Inspections	OAI	Warning letters	Recall records
2026	0	0	1	1
2025	2	1	0	1
2024	0	0	0	0
2023	0	0	0	0
2022	0	0	0	0
2021	0	0	0	0
2020	0	0	0	0
2019	2	0	0	5
2018	1	0	0	0
2017	0	0	1	3

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent recalls

10 recall records from Feb 16, 2017 to Mar 12, 2026.

Number	Class	Product	Date
H-0892-2026	Class III	Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato…	Mar 12, 2026
D-0298-2026	Class II	INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicone), 75-count…	Dec 19, 2025
D-0325-2020	Class III	Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato…	Oct 1, 2019
D-0322-2020	Class III	Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato…	Oct 1, 2019
D-0324-2020	Class III	WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3…	Oct 1, 2019
D-0303-2020	Class III	Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count…	Oct 1, 2019
D-0323-2020	Class III	Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato…	Oct 1, 2019
D-0854-2017	Class II	Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles…	Feb 16, 2017
D-0856-2017	Class II	DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL) bottles, Manufactured…	Feb 16, 2017
D-0855-2017	Class II	SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0.5 FL OZ (15mL)…	Feb 16, 2017

Recent FDA inspections

9 inspections from May 18, 2010 to Nov 21, 2025.

Date	Site	Product	Classification	FEI
Nov 21, 2025	Hachioji, Japan	Drugs	Official Action Indicated (OAI)	3004055563
May 5, 2025	Torrance, CA	Food/Cosmetics	No Action Indicated (NAI)	3026288295
Nov 7, 2019	Hachioji, Japan	Food/Cosmetics	No Action Indicated (NAI)	3004055563
Oct 25, 2019	Hachioji, Japan	Drugs	Voluntary Action Indicated (VAI)	3004055563
Jul 3, 2018	Hachioji, Japan	Drugs	Voluntary Action Indicated (VAI)	3004055563
Feb 12, 2016	Hachioji, Japan	Drugs	Official Action Indicated (OAI)	3004055563
Nov 16, 2012	Hachioji, Japan	Food/Cosmetics	No Action Indicated (NAI)	3004055563
Dec 21, 2010	Torrance, CA	Devices	No Action Indicated (NAI)	2082295
May 18, 2010	Torrance, CA	Food/Cosmetics	No Action Indicated (NAI)	2082295

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 2 compliance actions under Sato Pharmaceutical Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, May 19, 2026.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

3 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3004055563	Hachioji, Japan	6	Nov 21, 2025
FEI 3026288295	Torrance, CA	1	May 5, 2025
FEI 2082295	Torrance, CA	2	Dec 21, 2010

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