FDAClass IIIMay 9, 2018

Aptensio XR recall: Failed Dissolution

Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI…

Why was Aptensio XR recalled?

Failed Dissolution Specification: Low dissolution outside of specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# AG8679B Exp. 01/2020

Product
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI…
Recalling firm
Rhodes Pharmaceuticals, L.P.
Quantity
2454 bottles
Distribution
Nationwide within the USA
Recall date
May 9, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls