Food, drugs, devices › Sato Pharmaceutical Inc.
Drug recall: Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. West
FDA enforcement event 83964 is a drug recall by Sato Pharmaceutical Inc. of Torrance, CA, initiated 1 Oct 2019 and classified Class III, with 4 product records.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 22% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 18 Aug 2020. Initiation: voluntary: firm initiated. Sato Pharmaceutical Inc. has 4 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Sato Pharmaceutical Inc., Torrance, CA.
Reason for recall
"Subpotent Drug"
Distribution
"Nationwide within the United States, Guam and Saipan"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0322-2020 | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603 | 21,864 units | Class III | Terminated | 20 Nov 2019 |
| D-0323-2020 | Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 59779-534-01. UPC 050428345535 | 210,744 units | Class III | Terminated | 20 Nov 2019 |
| D-0324-2020 | WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) and b) 18-count boxes (NDC 0363-1407-02, UPC 3 11917-20318 8) Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, | a) 112,104 units b) 24,696 units | Class III | Terminated | 20 Nov 2019 |
| D-0325-2020 | Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946 | 39,504 units | Class III | Terminated | 20 Nov 2019 |
Context
Other enforcement events for Sato Pharmaceutical Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 12 Mar 2026 | Yunker(branded) Energy & Health Herbal Supplement with Vitamins; Manufactured by Sato Pharmaceuticals Co. Ltd.; 30ml con | Food | Class III | 1 |
| 1 Oct 2019 | Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by | Drug | Class III | 1 |
| 16 Feb 2017 | Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Manufactured by SATO Pharmaceu | Drug | Class II | 3 |
All 4 events for Sato Pharmaceutical Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Subpotent Drug"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide within the United States, Guam and Saipan"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Aug 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.