CLASS III Drug recall · Reported 20 Nov 2019 · FDA Enforcement Report
Motion Sickness (meclizine hydrochloride) recalled
Sato Pharmaceutical is recalling Motion Sickness (meclizine hydrochloride), distributed nationwide in the US. The recall was initiated on 1 Oct 2019 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0323-2020
- FDA event ID
- 83964
- Recalling firm
- Sato Pharmaceutical, Torrance, CA
- Manufacturer
- CVS Pharmacy, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Oct 2019
- FDA classified
- 13 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 1 Oct 2019 | Recall initiated by company | |
| 13 Nov 2019 | Classified by FDA | +43 days |
| 20 Nov 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States, Guam and Saipan
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: TXWP, TXTP, Exp. date Jul 2020; AXTZ, Exp. date Mar 2021; AXNP, Exp. date Jul 2021; AXBC, Exp. date Oct 2021; ZXWW, Exp. date Dec 2021
Where was it sold?
Nationwide within the United States, Guam and Saipan
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 83964| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Motion Sickness Strips (meclizine hydrochloride) 25 mg strips recalled | Sato Pharmaceutical | Potency & Assay | Nationwide | |
| CLASS III | Wal-dram 2 (meclizine Hydrochloride) recalled by Sato PharmaceuticalWal-dram 2 Quick-dissolving | Sato Pharmaceutical | Potency & Assay | Nationwide | |
| CLASS III | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips recalled | Sato Pharmaceutical | Potency & Assay | Nationwide |
More recalls from Sato Pharmaceutical
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Yunker(branded) Energy & Health Herbal Supplement with Vitamins recalledYunker | Sato Pharmaceutical | Other | Nationwide |
| Drug | CLASS II | INON ACE Antacid tablets (magnesium aluminosilicate recalledInon Ace | Sato Pharmaceutical | Other | CA, HI |
| Drug | CLASS III | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips recalled | Sato Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Wal-dram 2 (meclizine Hydrochloride) recalled by Sato PharmaceuticalWal-dram 2 Quick-dissolving | Sato Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Motion Sickness Strips (meclizine hydrochloride) 25 mg strips recalled | Sato Pharmaceutical | Potency & Assay | Nationwide |
Other Meclizine recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP, 25 mg cartons recalledMeclizine Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Meclizine HCl Tablets, 25 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Packaging Defects | NJ |
| Drug | CLASS II | Meclizine HCl Tablets, USP, 25 mg recalled by Wilshire Pharmaceuticals | Wilshire Pharmaceuticals | Potency & Assay | FL, TX |
| Drug | CLASS II | Meclizine HCl Tablets, USP, 12.5 mg recalled by Wilshire Pharmaceuticals | Wilshire Pharmaceuticals | Potency & Assay | FL, TX |