CLASS III Drug recall · Reported 20 Nov 2019 · FDA Enforcement Report

Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips recalled

Sato Pharmaceutical is recalling Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per, 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

Lot, batch or date codesLot #: TXWW, TXTW, Exp. date Dec 2019; AXPS, AXLS, AXBS AXNS, Exp. date Oct 2021; AXZL, AXAL, AXTL, AXWL, Exp. date Jun 2021.
Quantity recalled21,864 units

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-0322-2020
FDA event ID
83964
Recalling firm
Sato Pharmaceutical, Torrance, CA
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 2019Recall initiated by company
13 Nov 2019Classified by FDA+43 days
20 Nov 2019Published 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

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

Where it was distributed

Nationwide within the United States, Guam and Saipan

Nationwide

Questions about this recall

Why was it recalled?

Subpotent Drug

Which lots are affected?

Lot #: TXWW, TXTW, Exp. date Dec 2019; AXPS, AXLS, AXBS AXNS, Exp. date Oct 2021; AXZL, AXAL, AXTL, AXWL, Exp. date Jun 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

This product is part of a recall event; the main page for the event is Motion Sickness (meclizine hydrochloride) recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIIMotion Sickness (meclizine hydrochloride) recalledCvs Motion Sickness Fast MeltingSato PharmaceuticalPotency & AssayNationwide
CLASS IIIMotion Sickness Strips (meclizine hydrochloride) 25 mg strips recalledSato PharmaceuticalPotency & AssayNationwide
CLASS IIIWal-dram 2 (meclizine Hydrochloride) recalled by Sato PharmaceuticalWal-dram 2 Quick-dissolvingSato PharmaceuticalPotency & AssayNationwide

More recalls from Sato Pharmaceutical

All 10
ReportedClassRecallCompanyReasonWhere
FoodCLASS IIIYunker(branded) Energy & Health Herbal Supplement with Vitamins recalledYunkerSato PharmaceuticalOtherNationwide
DrugCLASS IIINON ACE Antacid tablets (magnesium aluminosilicate recalledInon AceSato PharmaceuticalOtherCA, HI
DrugCLASS IIIWal-dram 2 (meclizine Hydrochloride) recalled by Sato PharmaceuticalWal-dram 2 Quick-dissolvingSato PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIMotion Sickness Strips (meclizine hydrochloride) 25 mg strips recalledSato PharmaceuticalPotency & AssayNationwide
DrugCLASS IIIMotion Sickness (meclizine hydrochloride) recalledCvs Motion Sickness Fast MeltingSato PharmaceuticalPotency & AssayNationwide