PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: March 2, 2022 Initiated: February 7, 2022 #D-0573-2022

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

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.

Details

Recalling Firm
RISING PHARMACEUTICALS
Units Affected
2220 100-count bottles
Distribution
Nationwide in the USA
Location
East Brunswick, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by RISING PHARMACEUTICALS. Units affected: 2220 100-count bottles.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 2, 2022. Severity: Moderate. Recall number: D-0573-2022.