CLASS III Drug recall · Reported 14 Mar 2018 · FDA Enforcement Report
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg recalled
Osmotica Pharmaceutical is recalling Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, distributed nationwide in the US. The recall was initiated on 28 Feb 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0581-2018
- FDA event ID
- 79365
- Recalling firm
- Osmotica Pharmaceutical, Marietta, GA
- Manufacturer
- Trigen Laboratories, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 28 Feb 2018
- FDA classified
- 6 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 28 Feb 2018 | Recall initiated by company | |
| 6 Mar 2018 | Classified by FDA | +6 days |
| 14 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it 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.
Which lots are affected?
Lots: 170231B, 170232A, 170233A, 170234A
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Osmotica Pharmaceutical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg recalledMethylphenidate Hydrochloride | Osmotica Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg recalledMethylphenidate Hydrochloride | Osmotica Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Venlafaxine (Venlafaxine Hydrochloride) extended release recalled | Osmotica Pharmaceutical | Potency & Assay | Nationwide |
Other Methylphenidate recalls
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg recalledMethylphenidate Hydrochloride | Trigen Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Methylphenidate Hydrochloride Tablets, USP 20mg recalledMethylphenidate Hydrochloride | SUN Pharmaceutical Industries | Foreign Material | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 20mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 15 mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 10mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |