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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Wilshire Pharmaceuticals Inc: Meclizine HCl Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: February 16, 2021
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Summary

Wilshire Pharmaceuticals Inc. is recalling 38,040 bottles of Meclizine HCl tablets (12.5 mg and 25 mg), a prescription medication used to treat vertigo and motion sickness. The recall was initiated because the tablets failed dissolution specifications, meaning they may not dissolve properly in the body to release the active medicine. This defect can lead to the medication being less effective than intended for patients managing their symptoms.

Risk

If the tablets do not dissolve correctly, the patient may not receive the full dose of the medication at the expected time, potentially failing to control symptoms of vertigo or motion sickness. No specific injuries or adverse events have been reported in the recall data.

What You Should Do

  1. Check your prescription bottles for Meclizine HCl Tablets, USP, 12.5 mg (NDC 52536-129-01) with lot number 18030318 and expiration date 03/2021.
  2. Check your prescription bottles for Meclizine HCl Tablets, USP, 25 mg (NDC 52536-133-01) with lot numbers 18030329, 18030330, or 18030331 and expiration date 03/2021.
  3. If you have an affected product, contact your healthcare provider or pharmacist immediately to discuss alternative treatments and ensure your symptoms remain managed.
  4. Return any unused medication from the affected lots to the pharmacy where you purchased it for a refund.
  5. Contact Wilshire Pharmaceuticals Inc. at their Atlanta, Georgia headquarters if you have further questions regarding this recall.
  6. For additional information or to report a problem, contact the FDA Consumer Complaint hotline 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 to pharmacy.

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

Affected Products

Product: Meclizine HCl Tablets, USP, 12.5 mg (100 Tablets bottles)
Model:
NDC 52536-129-01
Recall #: D-0258-2021
Lot Numbers:
18030318 (Exp 03/2021)
Date Ranges: Exp 03/2021
Product: Meclizine HCl Tablets, USP, 25 mg (100 Tablets bottles)
Model:
NDC 52536-133-01
Recall #: D-0259-2021
Lot Numbers:
18030329 (Exp 03/2021)
18030330 (Exp 03/2021)
18030331 (Exp 03/2021)
Date Ranges: Exp 03/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87268
Status: Resolved
Manufacturer: Wilshire Pharmaceuticals Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2 products (2112 bottles; 35928 bottles)
Distributed To: Florida, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.