CLASS II Drug recall · Reported 10 Jul 2024 · FDA Enforcement Report
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg recalled
Trigen Laboratories is recalling Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, distributed nationwide in the US. The recall was initiated on 17 Jun 2024 and the FDA has classified it as Class II.
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-0579-2024
- FDA event ID
- 94818
- Recalling firm
- Trigen Laboratories, Alpharetta, GA
- Manufacturer
- Trigen Laboratories, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jun 2024
- FDA classified
- 2 Jul 2024
- Reported
- 10 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 17 Jun 2024 | Recall initiated by company | |
| 2 Jul 2024 | Classified by FDA | +15 days |
| 10 Jul 2024 | 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
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
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, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Which lots are affected?
Lot 230159M, Exp Date 2/28/2026
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Trigen Laboratories
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Triveen - PRx RNF Capsules recalled by Trigen Laboratories | Trigen Laboratories | Other | Nationwide |
Other Methylphenidate recalls
All 54| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Daytrana (methylphenidate transdermal system) CII, 30 mg recalledDaytrana | Noven Pharmaceuticals | Potency & Assay | Nationwide |