LISDEXAMFETAMINE DIMESYLATE

Generic: LISDEXAMFETAMINE DIMESYLATE

Elite LaboratoriesManufacturer
ORALRoute
LISDEXAMFETAMINE DIMESYLATEActive Substance
2024-11-15Original Approval

LISDEXAMFETAMINE DIMESYLATE is FDA application ANDA218604, sponsored by ELITE LABS 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 II2025-10-28
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

Failed Dissolution Specifications: An out of specification results observed in dissolution test duri

Class II2025-10-28
Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

Failed Dissolution Specifications: An out of specification results observed in dissolution test duri

Class II2025-06-16
Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only, Manufactured by: OHM Laboratories, New Bru

Failed Dissolution Specifications: An out of specification results observed in dissolution test duri

Class II2025-10-28
Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

Failed Dissolution Specifications: An out of specification results observed in dissolution test duri

Class II2025-10-28
Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

Failed Dissolution Specifications: An out of specification results observed in dissolution test duri

Class II2025-10-28
Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

Failed Dissolution Specifications: An out of specification results observed in dissolution test duri

Class II2025-10-28
Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

Failed Dissolution Specifications: An out of specification results observed in dissolution test duri

Class II2025-10-28
Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brun

Failed Dissolution Specifications: An out of specification results observed in dissolution test duri

Top Reported Reactions

1
DRUG INEFFECTIVE
1,082 reports
2
INTENTIONAL OVERDOSE
1,081 reports
3
INTENTIONAL SELF-INJURY
1,027 reports
4
PRODUCT AVAILABILITY ISSUE
503 reports
5
FATIGUE
486 reports
6
HEADACHE
457 reports
7
ANXIETY
444 reports
8
PRODUCT SUBSTITUTION ISSUE
437 reports
9
INABILITY TO AFFORD MEDICATION
387 reports
10
OFF LABEL USE
349 reports