Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

FDA Drug Recalls

982 recalls · Class II, 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 II · Moderate risk

TP Drug Laboratories Vitamin C ampules

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Terminated Unapproved drug Flawless Beauty LLC D-0331-2018
Class II · Moderate risk

Reiki Glutathione Whitening kits

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Terminated Unapproved drug Flawless Beauty LLC D-0330-2018
Class II · Moderate risk

Laennec INJ

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Terminated Unapproved drug Flawless Beauty LLC D-0329-2018
Class II · Moderate risk

Tationil Glutathione

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Terminated Unapproved drug Flawless Beauty LLC D-0328-2018
Class II · Moderate risk

Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Terminated Unapproved drug Flawless Beauty LLC D-0327-2018
Class II · Moderate risk

Tatiomax Gluatathione Whitening kits

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Terminated Unapproved drug Flawless Beauty LLC D-0326-2018
Class II · Moderate risk

Relumins Vitamin C Solvent ampules

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Terminated Unapproved drug Flawless Beauty LLC D-0325-2018
Class II · Moderate risk

Relumins Advanced Glutathione kits

Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.

Terminated Unapproved drug Flawless Beauty LLC D-0324-2018
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

Recalls by year