Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Methylphenidate Hydrochloride Extended-release Tablets Recalled by Osmotica Pharmaceutical Corp Due to Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL...

Date: February 28, 2018
Company: Osmotica Pharmaceutical Corp
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Osmotica Pharmaceutical Corp directly.

Affected Products

Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10

Quantity: 19,664 100-bottles

Why Was This Recalled?

Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Osmotica Pharmaceutical Corp

Osmotica Pharmaceutical Corp has 4 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report