METHYLPHENIDATE HYDROCHLORIDE

Generic: METHYLPHENIDATE HYDROCHLORIDE

Cranbury PharmaceuticalsManufacturer
ORALRoute
METHYLPHENIDATE HYDROCHLORIDEActive Substance
2010-07-23Original Approval

METHYLPHENIDATE HYDROCHLORIDE is FDA application ANDA091601, sponsored by TRIS PHARMA INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2022-02-07
Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceutic

Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufactu

Class II2023-07-13
Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc.

Presence of Foreign Substance: Metal embedded in a tablet.

Class III2017-12-18
Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC

Subpotent Drug

Class II2024-06-17
Methylphenidate Hydrochloride, Extended-release Tablets, USP, 36mg, 100-count Bottle, Rx Only, Manufactured for: Trigen

Failed dissolution specifications: this product is being recalled due to this batch not meeting diss

Class II2020-01-27
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals

CGMP deviations: Product bottle may be absent of desiccant.

Class II2020-01-27
Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals

CGMP deviations: Product bottle may be absent of desiccant.

Class III2017-12-18
Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC.

Subpotent Drug

Class III2018-02-28
Methylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC

Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to con

Top Reported Reactions

1
DRUG INEFFECTIVE
1,037 reports
2
HEADACHE
396 reports
3
FATIGUE
353 reports
4
ANXIETY
351 reports
5
OFF LABEL USE
333 reports
6
NAUSEA
328 reports
7
TOXICITY TO VARIOUS AGENTS
326 reports
8
PRODUCT SUBSTITUTION ISSUE
290 reports
9
DRUG ABUSE
279 reports
10
SOMNOLENCE
270 reports