Class II · Moderate risk
Ibuprofen Tablets USP
CGMP deviations: Ibuprofen is being recalled in response to previous recall
Is Ibuprofen recalled?
Yes — there is an active recall. 15 ongoing FDA recalls mention Ibuprofen (68 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ibuprofen. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Ibuprofen recalls on record
none so far in 2026; 68 on record, newest first
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Class II · Moderate risk
Ibuprofen Tablets
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.
Class I · High risk
Ibuprofen Lysine Injection
Presence of Particulate Matter
Class II · Moderate risk
Ibuprofen 10% cream
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Ibuprofen active pharmaceutical ingredient packaged in varying…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class I · High risk
Ibuprofen Tablets
Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544
Class II · Moderate risk
Smart Tab First Aid ezRefill System Ibuprofen dispenser boxes
First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).
Class III · Low risk
Advil PM Caplets
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Class II · Moderate risk
Concentrated Motrin
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Class II · Moderate risk
Ibu (NDC 55111-684-05)
Labeling: Incorrect or missing lot and/or exp date- This product is being recalled due to an incorrect expiration date of 05/2017. The correct expiration date is 10/2016.
Class II · Moderate risk
Children's Ibuprofen
CGMP Deviation: Discoloration; Product fails specification for appearance/color. A complaint was received regarding an abnormal appearance of children's ibuprofen suspension.
Class II · Moderate risk
Ibuprofen
Labeling:Label Mixup; IBUPROFEN, Tablet, 400 mg may be potentially mislabeled as ASPIRIN, Tablet, 325 mg, NDC 00536330501, Pedigree: W002573, EXP: 6/3/2014.
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