Class II · Moderate risk
Children's Ibuprofen Oral Suspension
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Is Ibuprofen recalled?
Yes — there is an active recall. 15 ongoing FDA recalls mention Ibuprofen (68 total). Check the affected lots below.
Most common reason: cGMP deviation (21 of these recalls)
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 in 2026
1 initiated in 2026, 68 in total — newest first
Class II · Moderate risk
Advil a) Ibuprofen
CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
Class II · Moderate risk
Acetaminophen and Ibuprofen
CGMP Deviations
Class III · Low risk
IBU (ibuprofen)
Failed Tablet/Capsule Specifications
Class II · Moderate risk
Ibuprofen 800mg
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Class II · Moderate risk
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk
IBU Ibuprofen Tablets
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II · Moderate risk
Ibuprofen and Famotidine Tablets 800mg/26.6mg
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Class II · Moderate risk
Advil Liqui-Gels Solubilized Ibuprofen Capsules
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Ibuprofen Tablets
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Ibuprofen Tablets
CGMP deviation: product outside labeled storage temperature requirements.
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil (ibuprofen)
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class II · Moderate risk
Motrin Ib Caplets 24ct Sku999394
CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk
Ibuprofen Tablets USP
cGMP deviations: Temperature abuse
Class II · Moderate risk
Ibuprofen Oral Suspension USP 100mg/5ml 120ml
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100…
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Class II · Moderate risk
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
Class II · Moderate risk
Ibuprofen Oral Suspension USP
Presence of foreign substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.
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