Rhodes Pharmaceuticals Recalls Aptensio XR Capsules Due to Dissolution Failure
Rhodes Pharmaceuticals is recalling Aptensio XR capsules because they failed to meet dissolution specifications. The affected lot was distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct safety hazard like contamination or mislabeling.
Plain-English summary
Rhodes Pharmaceuticals, L.P. is recalling Aptensio XR (methylphenidate HCl extended-release) capsules, 15 mg, 90-count bottles. The recall involves 2,454 bottles from Lot # AG8679B with an expiration date of 01/2020. The product was distributed nationwide within the United States.
The recall was initiated because the product failed to meet dissolution specifications, specifically showing low dissolution outside of the required standards. This defect means the medication may not release the active ingredient as intended.
Consumers who have this specific lot of Aptensio XR should stop using it and contact their healthcare provider or pharmacist for guidance. The product is marketed by Rhodes Pharmaceuticals, L.P., and manufactured by Patheon Manufacturing Services LLC.
The recalled product
- Product
- 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
- Manufacturer
- Rhodes Pharmaceuticals, L.P.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 2,454
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot# AG8679B Exp. 01/2020
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Rhodes Pharmaceuticals, L.P.
See all →- HighOxycodone Hydrochloride Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2021-09-22
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
Similar recalls
- LowNovartis Recalls Dexmethylphenidate HCl Extended-Release Capsules for Dissolution Failure
FDA (Drugs) · 2015-09-23
- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateDr. Reddy's Fexofenadine/Pseudoephedrine Tablets Fail Dissolution Specification
FDA (Drugs) · 2022-01-26
- ModerateActavis Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2017-02-22
- LowPfizer Recalls Quillivant XR Methylphenidate Suspension for Dissolution Failures
FDA (Drugs) · 2017-09-27
- LowCVS Allergy & Congestion Relief Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2021-12-15