FDA Drug recall D-0573-2022
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Br…
- FDA Drug
- Class II
- ongoing
- Published 2022-03-02
On 2022-03-02 the FDA classified a Class II recall of Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Br… by Rising Pharmaceuticals, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0573-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-02-07 |
| Published | 2022-03-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Rising Pharmaceuticals |
| Distribution | US |
Product
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
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.
Identifiers
| ndc | 64980-221-01 |
|---|---|
| ndc | 64980-222-01 |
| ndc | 64980-223-01 |
| code_info | lot# 25910009, Exp 01/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0573-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.