Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Feb 28, 2018 (9 years ago)

Methylphenidate Hydrochloride Extended-release Tablets

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

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.

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

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

Affected NDC 13811-0708-10

Compare with the code on your package — it is the most precise check available.

Drug: Methylphenidate

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Methylphenidate Hydrochloride
NDC 13811-0708		 36 mg/1 Tablet, Extended Release
Oral		 Trigen Laboratories, LLC Rx · CII
Recalling firm
Osmotica Pharmaceutical Corp
NDC code
13811-708-10
Origin
GA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0581-2018 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Methylphenidate recalls

See all
Class II · Moderate risk

Methylphenidate Hydrochloride

Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.

Terminated Dissolution failure Trigen Laboratories NDC 13811-708-10 D-0579-2024

Other recalls by Osmotica Pharmaceutical Corp

All 2018 recalls
Class III · Low risk

Venlafaxine

Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.

Terminated Dissolution failure Osmotica Pharmaceutical Corp NDC 0131-3268-32 D-1067-2013