Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA drug recalls in 2018

Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.

1,681 recalls, newest first.

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2018 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Senna Laxative

Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg.

Terminated Labeling / mix-up Magno Humphries Laboratories, Inc D-0342-2018
Class III · Low risk

Vecuronium bromide for Injection

Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.

Terminated Impurity / degradation Fresenius Kabi USA, LLC NDC 63323-781-10 D-0426-2018
Class II · Moderate risk

Pravastatin Sodium Tablets

Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

Terminated Particulate / foreign matter International Laboratories, Inc. NDC 54458-926-16 D-0234-2018
Class II · Moderate risk

Pravastatin Sodium Tablets

Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.

Terminated Particulate / foreign matter International Laboratories, Inc. NDC 54458-927-16 D-0233-2018
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

Recalls by year