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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Rising Pharmaceuticals Methylphenidate Hydrochloride Recalled for Oversized Tablets

Agency Publication Date: February 22, 2022
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Summary

Rising Pharmaceuticals has voluntarily recalled 2,220 bottles of Methylphenidate Hydrochloride chewable tablets (2.5 mg), a medication used to treat ADHD. The recall was issued after two reports were received of a tablet in a sealed bottle being twice the size of the other tablets. Consuming an oversized tablet would result in a patient receiving double the intended dose of medication. These 100-count bottles were distributed to pharmacies nationwide across the United States.

Risk

An oversized tablet contains twice the intended amount of medication, which can lead to an accidental overdose and serious adverse health effects. While no injuries have been reported to date, the manufacturer is recalling the product to prevent potential harm from failed dosage specifications.

What You Should Do

  1. The recalled product is Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, sold in 100-count bottles under the Rising Pharmaceuticals brand.
  2. Check the bottle label for NDC 64980-221-01 and lot number 25910009 with an expiration date of 01/2023.
  3. If you have health concerns or suspect you have taken an incorrect dose, contact your healthcare provider or pharmacist immediately.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Rising Pharmaceuticals for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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: Methylphenidate Hydrochloride Chewable Tablets (100-count bottle)
Variants: 2.5 mg, Chewable Tablet
Lot Numbers:
25910009 (Exp 01/2023)
NDC:
64980-221-01

Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863. Recall #: D-0573-2022.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89545
Status: Active
Manufacturer: RISING PHARMACEUTICALS
Sold By: Pharmacies
Manufactured In: United States
Units Affected: 2220 100-count 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 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.