Class II · Moderate risk
Methylphenidate Hydrochloride
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Methylphenidate Hydrochloride Extended-release Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug
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 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10
Affected NDC
13811-0709-10
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.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Methylphenidate Hydrochloride NDC 13811-0709 |
54 mg/1 | Tablet, Extended Release Oral |
Trigen Laboratories, LLC | Rx · CII |
- Recalling firm
- Osmotica Pharmaceutical Corp
- NDC code
- 13811-709-10
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0111-2018 · 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 Tablets
Presence of Foreign Substance: Metal embedded in a tablet.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of specification for shear.
Other recalls by Osmotica Pharmaceutical Corp
All 2017 recalls
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Class III · Low risk
Methylphenidate Hydrochloride Extended-release Tablets
Subpotent Drug
Class III · Low risk
Venlafaxine
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
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