US Drug Recall Register

FDA Drug Recalls

17,898 recalls, newest first

Class I · High risk Terminated

Senna Laxative

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

Magno Humphries Laboratories, Inc D-0342-2018
Class III · Low risk Terminated

Vecuronium bromide for Injection

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

Fresenius Kabi USA, LLC NDC 63323-781-10 D-0426-2018
Class I · High risk Terminated

Hcg 5

Reason Non-Sterility

The Compounding Pharmacy of America D-0600-2018
Class I · High risk Terminated

Levofloxacin in 5% Dextrose Injection

Reason Presence of Particulate Matter; contains visible particulate matter identified as mold.

AuroMedics Pharma LLC NDC 55150-243-46 D-0574-2018
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
Class II · Moderate risk Terminated

Aripiprazole Tablets

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

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

Ibuprofen Tablets USP

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

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

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

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

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

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