Why it was recalled
Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
Product description
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
Lot numbers, UPCs & expiration codes
Lot 230159M, Exp Date 2/28/2026
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0579-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 17, 2024
- FDA report date
- Jul 10, 2024
- Quantity
- 10,448 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Trigen Laboratories
Original FDA data
Every field from FDA enforcement report D-0579-2024, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 94818
- Address
- 1880 Mcfarland Pkwy
- Address (line 2)
- ste 110
- Code information
- Lot 230159M, Exp Date 2/28/2026
- Postal code
- 30005-1794
- Report date
- Jul 10, 2024
- Product type
- Drugs
- Recall number
- D-0579-2024
- Classification
- Class II
- Recalling firm
- Trigen Laboratories
- Product quantity
- 10,448 100-count bottles
- Termination date
- Sep 23, 2025
- Reason for recall
- Failed dissolution specifications: this product is being recalled due to this batch not meeting dissolution specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen Laboratories, LLC, Alpharetta, GA 30005, NDC 13811-708-10
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 17, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 2, 2024