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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

Osmotica Pharmaceutical Corp: Methylphenidate HCL ER Tablets Recalled for Subpotency

Agency Publication Date: March 6, 2018
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Summary

Osmotica Pharmaceutical Corp is recalling 19,664 bottles of Trigen Laboratories Methylphenidate Hydrochloride Extended-release (ER) Tablets, USP, 36 mg. This recall was initiated because some 100-count bottles labeled as 36 mg tablets were found to contain a single 27 mg tablet instead. This means patients may receive a lower dose of medication than prescribed. Consumers should contact their healthcare provider or pharmacist regarding this medication.

Risk

A patient unknowingly taking a 27 mg tablet instead of the prescribed 36 mg dose will receive a lower amount of medication than intended. This subpotent dosing may lead to a temporary reduction in the effectiveness of the treatment for their condition.

What You Should Do

  1. Identify your medication by checking the bottle for 'Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle' with NDC 13811-708-10.
  2. Check the bottle for one of the following affected lot numbers: 170231B, 170232A, 170233A, or 170234A.
  3. If your bottle matches these lot numbers, contact your healthcare provider or pharmacist for guidance on your treatment and to report the issue.
  4. Return any unused product from the affected lots to your pharmacy for a refund and contact Osmotica Pharmaceutical Corp for further instructions.
  5. For additional questions, 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

Healthcare consultation and pharmacy refund.

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

Affected Products

Product: Trigen Laboratories Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg (100-count bottle)
Model:
NDC 13811-708-10
Lot Numbers:
170231B
170232A
170233A
170234A

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 79365
Status: Resolved
Manufacturer: Osmotica Pharmaceutical Corp
Sold By: pharmacies
Manufactured In: United States
Units Affected: 19,664 100-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.