Why it was recalled
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
Product description
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
Lot numbers, UPCs & expiration codes
lot# 25910009, Exp 01/2023
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-0573-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 7, 2022
- FDA report date
- Mar 2, 2022
- Quantity
- 2220 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RISING PHARMACEUTICALS
Original FDA data
Every field from FDA enforcement report D-0573-2022, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 89545
- Address
- 2 Tower Center Blvd
- Code information
- lot# 25910009, Exp 01/2023
- Postal code
- 08816-1100
- Report date
- Mar 2, 2022
- Product type
- Drugs
- Recall number
- D-0573-2022
- Classification
- Class II
- Recalling firm
- RISING PHARMACEUTICALS
- Product quantity
- 2220 100-count bottles
- Reason for recall
- Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 22, 2022