Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,724 recalls · Class II, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

WipeEssentials Wet Wipes

CGMP Deviations: finished products were manufactured with poor quality water.

Terminated cGMP deviation Diamond Wipes International, Inc. D-0630-2018
Class II · Moderate risk

Acure

CGMP Deviations: finished products were manufactured with poor quality water.

Terminated cGMP deviation Diamond Wipes International, Inc. D-0629-2018
Class II · Moderate risk

Zhong Hua Jiu

CGMP Deviations: the product was produced with substandard GMP manufacturing processes.

Terminated cGMP deviation United Pacific Co Ltd NDC 53614-001-02 D-0624-2018
Class II · Moderate risk

Molleave

cGMP Deviations

Terminated cGMP deviation Elroselabs Inc. D-0622-2018
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Terminated cGMP deviation American Health Packaging NDC 60687-179-11 D-0595-2018
Class II · Moderate risk

Ibuprofen Caplets USP 200 mg

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

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 53943-292-15 D-0695-2018
Class II · Moderate risk

Ibuprofen Caplets USP 200 mg

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

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 49483-600-05 D-0694-2018
Class II · Moderate risk

Ibuprofen Tablets USP 800 mg

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

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 42582-113-10 D-0693-2018
Class II · Moderate risk

Ibuprofen Tablets USP 800 mg

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

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 49483-604-01 D-0692-2018
Class II · Moderate risk

Ibuprofen Tablets USP 600 mg

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

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 42582-112-01 D-0691-2018
Class II · Moderate risk

Ibuprofen Tablets USP 600 mg

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

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 42582-112-10 D-0690-2018
Class II · Moderate risk

Ibuprofen Tablets USP 600 mg

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

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 49483-603-01 D-0689-2018
Class II · Moderate risk

Ibuprofen Tablets USP 400 mg

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

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 42582-111-18 D-0688-2018
Class II · Moderate risk

Ibuprofen Tablets USP 400 mg

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

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 49483-602-01 D-0687-2018
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.

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 53943-291-15 D-0686-2018
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.

Terminated cGMP deviation Time-Cap Laboratories, Inc. NDC 49483-601-05 D-0685-2018
Class II · Moderate risk

Aripiprazole Tablets

CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.

Terminated cGMP deviation Hetero Labs, Ltd. - Unit III NDC 31722-827-30 D-0594-2018
Class II · Moderate risk

Ibuprofen Tablets USP

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

Terminated cGMP deviation Spirit Pharmaceuticals, LLC NDC 68210-0800-1 D-0583-2018
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.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-123-27 D-0240-2018
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.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-122-28 D-0239-2018
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.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-121-29 D-0238-2018
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.

Terminated cGMP deviation Marksans Pharma Inc. NDC 25000-114-30 D-0237-2018

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