IBUPROFEN

Generic: IBUPROFEN

Sun Pharmaceutical IndustriesManufacturer
ORALRoute
IBUPROFENActive Substance
2021-02-22Original Approval

IBUPROFEN is FDA application ANDA211666, sponsored by STRIDES PHARMA. 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 II2018-01-10
Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779,

CGMP deviations: Ibuprofen is being recalled in response to previous recall

Class II2017-06-16
Ibuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, Inc., 7 Mich

Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain s

Class II2018-01-11
Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufac

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints

Class II2018-01-11
Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufac

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints

Class II2018-01-09
Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints

Class II2019-09-27
Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Bra

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert pl

Class II2026-03-02
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceutica

Presence of foreign substance: the firm received complaints for a gel-like mass and black particles

Class II2018-01-11
Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufac

CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints

Class II2025-03-13
Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count pack

CGMP Deviations

Class II2019-09-27
Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Dis

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert pl

Top Reported Reactions

1
DRUG INEFFECTIVE
17,143 reports
2
PAIN
15,273 reports
3
FATIGUE
14,809 reports
4
NAUSEA
13,811 reports
5
HEADACHE
12,365 reports
6
ARTHRALGIA
11,032 reports
7
DYSPNOEA
10,718 reports
8
VOMITING
10,215 reports
9
DIARRHOEA
9,918 reports
10
RASH
9,161 reports