US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated

Ling Zhi capsules

Reason 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.

Flawless Beauty LLC D-0333-2018
Class II · Moderate risk Terminated

Sterilized water for injections BP

Reason 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.

Flawless Beauty LLC D-0332-2018
Class II · Moderate risk Terminated

TP Drug Laboratories Vitamin C ampules

Reason 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.

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

Reiki Glutathione Whitening kits

Reason 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.

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

Laennec INJ

Reason 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.

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

Tationil Glutathione

Reason 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.

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

Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm

Reason 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.

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

Tatiomax Gluatathione Whitening kits

Reason 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.

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

Relumins Vitamin C Solvent ampules

Reason 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.

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

Relumins Advanced Glutathione kits

Reason 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.

Flawless Beauty LLC D-0324-2018
Class II · Moderate risk Terminated

Pravastatin Sodium Tablets

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

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

Pravastatin Sodium Tablets

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

International Laboratories, Inc. NDC 54458-927-16 D-0233-2018
Class II · Moderate risk Terminated

Ibuprofen Caplets USP 200 mg

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

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

Ibuprofen Caplets USP 200 mg

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

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

Ibuprofen Tablets USP 800 mg

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

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

Ibuprofen Tablets USP 800 mg

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

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

Ibuprofen Tablets USP 600 mg

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

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

Ibuprofen Tablets USP 600 mg

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

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

Ibuprofen Tablets USP 600 mg

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

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

Ibuprofen Tablets USP 400 mg

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

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

Ibuprofen Tablets USP 400 mg

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

Time-Cap Laboratories, Inc. NDC 49483-602-01 D-0687-2018
Class II · Moderate risk Terminated

Ibuprofen Tablets

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

Time-Cap Laboratories, Inc. NDC 53943-291-15 D-0686-2018
Class II · Moderate risk Terminated

Ibuprofen Tablets

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

Time-Cap Laboratories, Inc. NDC 49483-601-05 D-0685-2018