Recalls / Class II
Class IID-0579-2024
Product
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
- Brand name
- Methylphenidate Hydrochloride
- Generic name
- Methylphenidate Hydrochloride
- Active ingredient
- Methylphenidate Hydrochloride
- Route
- Oral
- NDCs
- 13811-706, 13811-709, 13811-707, 13811-708, 13811-710
- FDA application
- ANDA205327
- Affected lot / code info
- Lot 230159M, Exp Date 2/28/2026
Why it was recalled
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Recalling firm
- Firm
- Trigen Laboratories
- Manufacturer
- Trigen Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1880 Mcfarland Pkwy, ste 110, Alpharetta, Georgia 30005-1794
Distribution
- Quantity
- 10,448 100-count bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-06-17
- FDA classified
- 2024-07-02
- Posted by FDA
- 2024-07-10
- Terminated
- 2025-09-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0579-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.