Medications & Supplements/Over-the-Counter

Rising Pharmaceuticals Meclizine HCl Tablets Recalled for Labeling Error

Agency Publication Date: October 7, 2021

Summary

Rising Pharmaceuticals has recalled 1,344 bottles of Meclizine HCl tablets (25 mg), an antihistamine used to treat motion sickness and vertigo. The recall was initiated because the product labels contain incorrect dosage instructions. The affected medication is packaged in 100-count HDPE bottles from Lot CB21024 with an expiration date of February 2023.

Risk

Incorrect dosage instructions on a medication label can cause patients to take the wrong amount of the drug. This can lead to the medication being ineffective or may cause unexpected side effects if too much is consumed. No injuries or incidents have been reported to date.

What You Should Do

This recall involves Meclizine HCl Tablets, 25 mg, sold in 100-count HDPE bottles under NDC 16571-752-01.
Identify affected bottles by checking for lot number CB21024 and an expiration date of 2/2023 printed on the label.
If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Rising Pharmaceuticals for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report a problem.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Meclizine HCl Tablets (100-count)

Variants: 25 mg, Tablet

Lot Numbers:

CB21024 (Exp 2/2023)

NDC:

16571-752-01

Distributed by Rising Pharma Holdings, Inc.; Manufactured by Aurex laboratories LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88593

Status: Active

Manufacturer: RISING PHARMACEUTICALS

Sold By: pharmacies; healthcare providers

Manufactured In: United States

Units Affected: 1,344 bottles

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

This recall involves Meclizine HCl Tablets, 25 mg, sold in 100-count HDPE bottles under NDC 16571-752-01.

Identify affected bottles by checking for lot number CB21024 and an expiration date of 2/2023 printed on the label.

If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Rising Pharmaceuticals for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions or to report a problem.