Osmotica Pharmaceutical Methylphenidate Hydrochloride Recall

Why it was 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.

Product description

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

Lot numbers, UPCs & expiration codes

Lots: 170231B, 170232A, 170233A, 170234A

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0581-2018
Classification: Class III
Status: Terminated
Recall initiated: Feb 28, 2018
FDA report date: Mar 14, 2018
Quantity: 19,664 100-bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Osmotica Pharmaceutical Corp

Original FDA data

Every field from FDA enforcement report D-0581-2018, exactly as published.

Show all FDA fields

City: Marietta
State: GA
Status: Terminated
Country: United States
Event ID: 79365
Address: 895 Sawyer Rd
Code information: Lots: 170231B, 170232A, 170233A, 170234A
Postal code: 30062-2257
Report date: Mar 14, 2018
Product type: Drugs
Recall number: D-0581-2018
Classification: Class III
Recalling firm: Osmotica Pharmaceutical Corp
Product quantity: 19,664 100-bottles
Termination date: May 1, 2019
Reason for recall: Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Distribution pattern: Nationwide in the USA
Recall initiation date: Feb 28, 2018
Initial firm notification: Letter
Center classification date: Mar 6, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0581-2018, published Mar 14, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.