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Ibuprofen

FDA recalls

13 rows

DateCompany and reasonClass
Mar 1, 2026Strides Pharma Inc
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.		Class II · Ongoing
Oct 28, 2024Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specifications		Class III · Ongoing
Aug 5, 2024Dr. Reddy's Laboratories, Inc.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.		Class II · Ongoing
Apr 12, 2022McKesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse		Class II · Terminated
Oct 21, 2020Aurobindo Pharma USA Inc.
Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.		Class III · Terminated
Mar 15, 2020GlaxoSmithKline Consumer Healthcare Holdings
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.		Class II · Terminated
Sep 26, 2019Taro Pharmaceuticals U.S.A., Inc.
Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.		Class II · Terminated
Aug 22, 2018Pfizer Global Supply
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.		Class II · Terminated
Jan 10, 2018Time-Cap Laboratories, Inc.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.		Class II · Terminated
Jan 9, 2018Spirit Pharmaceuticals, LLC
CGMP deviations: Ibuprofen is being recalled in response to previous recall		Class II · Terminated
Jan 8, 2018Marksans Pharma Inc.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.		Class II · Terminated
Jun 15, 2017Time-Cap Laboratories, Inc.
Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg.		Class II · Terminated
Aug 28, 2013Dr. Reddy's Laboratories, Inc.
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 · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).