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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 Hydrochloride Extended-Release Recalled for Subpotency

Agency Publication Date: December 20, 2017
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Summary

Osmotica Pharmaceutical Corp is recalling approximately 19,983 bottles of Methylphenidate Hydrochloride Extended-release Tablets (the generic version of Concerta), used to treat ADHD. This recall includes both 27 mg and 54 mg dosage strengths sold in 100-count bottles under the Trigen Laboratories label. The medication is being recalled because it is subpotent, meaning the tablets may not contain the full amount of active medicine required, which can lead to reduced effectiveness in managing symptoms. Consumers should contact their healthcare provider or pharmacist to discuss alternative treatments and return the affected product to their pharmacy.

Risk

The tablets are subpotent and do not meet the required strength specifications, which may result in patients receiving a lower dose than prescribed. This can cause a failure to control symptoms of ADHD, such as inattention, impulsivity, or hyperactivity.

What You Should Do

  1. Check your prescription bottle label to see if you have Methylphenidate Hydrochloride Extended-release Tablets from Trigen Laboratories, LLC.
  2. For 27 mg tablets (100-count bottles), look for NDC 13811-707-10 and Lot 170027A with an expiration date of 02/2019.
  3. For 54 mg tablets (100-count bottles), look for NDC 13811-709-10 and check for Lot 170029A or Lot 170030A, both with expiration dates of 02/2019.
  4. If you identify your medication as part of this recall, contact your healthcare provider or pharmacist immediately for guidance on a replacement prescription.
  5. Return any unused medication from the affected lots to your pharmacy for a refund and further instructions.
  6. Contact Osmotica Pharmaceutical Corp or the distributor at 895 Sawyer Rd, Marietta, Georgia, 30062-2257 for more information regarding this recall.
  7. 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

Contact healthcare provider or pharmacist and return for refund.

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 Extended-release Tablets, USP (27 mg, 100-count bottles)
Model:
NDC 13811-707-10
Recall #: D-0110-2018
Lot Numbers:
170027A (Exp. 02/2019)
Date Ranges: Expiration 02/2019
Product: Methylphenidate Hydrochloride Extended-release Tablets, USP (54 mg, 100-count bottles)
Model:
NDC 13811-709-10
Recall #: D-0111-2018
Lot Numbers:
170029A (Exp. 02/2019)
170030A (Exp. 02/2019)
Date Ranges: Expiration 02/2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78764
Status: Resolved
Manufacturer: Osmotica Pharmaceutical Corp
Sold By: Trigen Laboratories, LLC; Pharmacies nationwide
Manufactured In: United States
Units Affected: 2 products (10064 bottles; 9919 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.