CLASS III Drug recall · Reported 9 May 2018 · FDA Enforcement Report
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg recalled
Rhodes Pharmaceuticals is recalling Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg, distributed nationwide in the US. The recall was initiated on 17 Apr 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0710-2018
- FDA event ID
- 79820
- Recalling firm
- Rhodes Pharmaceuticals, Coventry, RI
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Apr 2018
- FDA classified
- 3 May 2018
- Reported
- 9 May 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- ADHD Medication
Timeline
| 17 Apr 2018 | Recall initiated by company | |
| 3 May 2018 | Classified by FDA | +16 days |
| 9 May 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specification: Low dissolution outside of specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg Rx Only 90-count bottle. Marketed by: Rhodes Pharmaceuticals L.P., Coventry, RI 02816. Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834. NDC 42858-402-45
Where it was distributed
Nationwide within the USA
Questions about this recall
Is Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg recalled?
Yes. Rhodes Pharmaceuticals recalled Aptensio XR (methylphenidate HCl extended-release) capsules 15 mg on 17 Apr 2018. The recall is Class III and its status is Terminated. Recall number D-0710-2018.
Why was it recalled?
Failed Dissolution Specification: Low dissolution outside of specifications
Which lots are affected?
Lot# AG8679B Exp. 01/2020
Where was it sold?
Nationwide within the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Rhodes Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP, 10 mg recalledOxycodone Hydrochloride | Rhodes Pharmaceuticals | Other | Nationwide |