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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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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Teva Pharmaceuticals USA: Methylphenidate Hydrochloride Tablets Recalled for Failed Dissolution

Agency Publication Date: October 24, 2017
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Summary

Teva Pharmaceuticals USA is voluntarily recalling approximately 58,292 bottles of Methylphenidate Hydrochloride (generic Ritalin), 20 mg tablets, because the medication failed dissolution testing. This failure means the tablets may not break down properly in the body, which can result in the medication being less effective than intended. The recall affects 100-count bottles manufactured by Watson Laboratories and distributed nationwide throughout the United States and Puerto Rico.

Risk

If the medication does not dissolve correctly, the patient may receive a lower dose of the active ingredient than prescribed. This could lead to inconsistent treatment of conditions like ADHD and potentially cause symptoms to return or worsen.

What You Should Do

  1. Check your prescription bottles for Methylphenidate Hydrochloride Tablets USP, 20 mg, in 100-count containers.
  2. Verify the label for NDC number 0591-5884-01 and specifically look for Lot Number 1156086M with an expiration date of 08/18.
  3. If you have the affected medication, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment.
  4. Return any unused tablets from the affected lot to the pharmacy where you purchased them for a refund.
  5. Contact the distributor, Teva Pharmaceuticals USA, for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint line at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund and medical guidance

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

Affected Products

Product: Methylphenidate Hydrochloride Tablets USP, 20 mg (100-count bottles)
Model:
NDC 0591-5884-01
Recall #: D-0052-2018
Lot Numbers:
1156086M (Exp 08/18)
Date Ranges: Exp 08/18

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78308
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA
Manufactured In: United States
Units Affected: 58,292 bottles
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.