Sato Pharmaceutical recalls
FDA enforcement reports naming Sato Pharmaceutical Co., Ltd as the recalling firm.
- Recall reports
- 10
- Class I (serious)
- 0
- Most recent report
- Jun 10, 2026
- Jun 10, 2026Yunker(branded) Energy & Health Herbal Supplement with VitaminsFood · Sato Pharmaceutical Inc.Product does not meet label claim for Vitamin E.Class III
- Feb 4, 2026INON ACE Antacid tablets (magnesium aluminosilicate, magnesium hydroxide and simethicon…Drug · Sato Pharmaceutical Co., LtdFailed Disintegration Specifications: above the time expected.Class II
- Nov 20, 2019Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed…Drug · Sato Pharmaceutical Inc.Subpotent DrugClass III
- Nov 20, 2019Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by S…Drug · Sato Pharmaceutical Inc.Subpotent DrugClass III
- Nov 20, 2019Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato…Drug · Sato Pharmaceutical Inc.Subpotent DrugClass III
- Nov 20, 2019WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1…Drug · Sato Pharmaceutical Inc.Subpotent DrugClass III
- Nov 13, 2019Sankaijo BOTANICAL LAXATIVE (docusate sodium 8Drug · Sato Pharmaceutical Inc.Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.Class III
- May 31, 2017SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged in 0Drug · Sato Pharmaceutical Inc.Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.Class II
- May 31, 2017DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0Drug · Sato Pharmaceutical Inc.Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.Class II
- May 31, 2017Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0Drug · Sato Pharmaceutical Inc.Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.Class II