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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

Sato Pharmaceutical Inc.: Meclizine Hydrochloride Products Recalled for Subpotency

Agency Publication Date: November 13, 2019
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Summary

Sato Pharmaceutical Inc. is recalling 384,216 units of Zentrip, WAL-DRAM 2, and other motion sickness medications containing meclizine hydrochloride. These products are being recalled because they were found to be subpotent, meaning they may not contain the full labeled amount of active medication. The recall affects various formats including tablets and oral strips distributed nationwide within the United States, Guam, and Saipan.

Risk

Subpotent medication may not provide the intended level of treatment for motion sickness symptoms, such as nausea, dizziness, and vomiting, potentially leading to ineffective symptom management for the consumer.

What You Should Do

  1. Check your medicine cabinet for Zentrip (meclizine Hydrochloride) 25 mg strips (8-count) with NDC 49873-803-01 and UPC 4987301603. Look for lot numbers TXWW, TXTW (Exp Dec 2019), AXPS, AXLS, AXBS, AXNS (Exp Oct 2021), or AXZL, AXAL, AXTL, AXWL (Exp Jun 2021).
  2. Check for Motion Sickness (meclizine hydrochloride) 25 mg tablets (12-count) with NDC 59779-534-01 and UPC 050428345535. Look for lot numbers TXWP, TXTP (Exp Jul 2020), AXTZ (Exp Mar 2021), AXNP (Exp Jul 2021), AXBC (Exp Oct 2021), or ZXWW (Exp Dec 2021).
  3. Check for WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets in 12-count boxes (NDC 0363-1407-01, UPC 3 11917-18328 2) or 18-count boxes (NDC 0363-1407-02, UPC 3 11917-20318 8). Look for lot numbers AXWA (Exp Feb 2021), AXAB (Exp May 2021), AXLK (Exp Nov 2021), or AXZP (Exp Jul 2021).
  4. Check for Motion Sickness Strips (meclizine hydrochloride) 25 mg strips (8-count) with NDC 69842-288-01 and UPC 5042849946. Look for lot numbers AXTK, AXAK, AXZK, AXNK, AXBK, AXLK, AXPK, or AXCK with expiration dates of Nov 2021.
  5. If you have any of the affected products, contact your healthcare provider or pharmacist for guidance on alternative treatments. Return any unused product to the place of purchase for a full refund.
  6. Contact Sato Pharmaceutical Inc. at their Torrance, California office for further instructions regarding this recall.
  7. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Zentrip (meclizine Hydrochloride) 25 mg strips (8-strips per box)
Model:
NDC 49873-803-01
UPC Codes:
4987301603
Lot Numbers:
TXWW (Exp Dec 2019)
TXTW (Exp Dec 2019)
AXPS (Exp Oct 2021)
AXLS (Exp Oct 2021)
AXBS (Exp Oct 2021)
AXNS (Exp Oct 2021)
AXZL (Exp Jun 2021)
AXAL (Exp Jun 2021)
AXTL (Exp Jun 2021)
AXWL (Exp Jun 2021)
Date Ranges: Dec 2019, Jun 2021, Oct 2021
Product: Motion Sickness (meclizine hydrochloride) 25 mg tablets (12-count box)
Model:
NDC 59779-534-01
UPC Codes:
050428345535
Lot Numbers:
TXWP (Exp Jul 2020)
TXTP (Exp Jul 2020)
AXTZ (Exp Mar 2021)
AXNP (Exp Jul 2021)
AXBC (Exp Oct 2021)
ZXWW (Exp Dec 2021)
Date Ranges: Jul 2020, Mar 2021, Jul 2021, Oct 2021, Dec 2021
Product: WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets (12-count)
Model:
NDC 0363-1407-01
UPC Codes:
311917183282
Lot Numbers:
AXWA (Exp Feb 2021)
AXAB (Exp May 2021)
AXLK (Exp Nov 2021)
Date Ranges: Feb 2021, May 2021, Nov 2021
Product: WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets (18-count)
Model:
NDC 0363-1407-02
UPC Codes:
311917203188
Lot Numbers:
AXZP (Exp Jul 2021)
Date Ranges: Jul 2021
Product: Motion Sickness Strips (meclizine hydrochloride) 25 mg strips (8-count box)
Model:
NDC 69842-288-01
UPC Codes:
5042849946
Lot Numbers:
AXTK (Exp Nov 2021)
AXAK (Exp Nov 2021)
AXZK (Exp Nov 2021)
AXNK (Exp Nov 2021)
AXBK (Exp Nov 2021)
AXLK (Exp Nov 2021)
AXPK (Exp Nov 2021)
AXCK (Exp Nov 2021)
Date Ranges: Nov 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83964
Status: Resolved
Manufacturer: Sato Pharmaceutical Inc.
Manufactured In: United States
Units Affected: 4 products (21,864 units; 210,744 units; a) 112,104 units b) 24,696 units; 39,504 units)
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.