FDA Drug Recalls

17,898 recalls, newest first

Class I · High risk Terminated Jan 17, 2018

Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC…

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 Jan 16, 2018

Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC…

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 II · Moderate risk Terminated Jan 16, 2018

DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical…

Reason Lack Of Assurance Of Sterility

Sun Pharmaceutical Industries, Inc. NDC 47335-049-40 D-0229-2018

Class I · High risk Terminated Jan 12, 2018

HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding…

Reason Non-Sterility

The Compounding Pharmacy of America D-0600-2018

Class I · High risk Terminated Jan 12, 2018

Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for…

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 Jan 12, 2018

Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per…

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 Jan 12, 2018

Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per…

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 Jan 11, 2018

Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC…

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 Jan 11, 2018

Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC…

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 Jan 11, 2018

Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by…

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 Jan 11, 2018

Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured…

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 Jan 11, 2018

Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug…

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 Jan 11, 2018

Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by…

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 Jan 11, 2018

Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured…

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 Jan 11, 2018

Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International…

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 Jan 11, 2018

Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured…

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 Jan 11, 2018

Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC…

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 Jan 11, 2018

Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC…

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 Jan 11, 2018

Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way…

Reason Labeling: Label Error on Declared Strength

Premier Pharmacy Labs Inc D-0251-2018

Class II · Moderate risk Terminated Jan 10, 2018

Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854…

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 Jan 10, 2018

Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC…

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 Jan 9, 2018

Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only…

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 Jan 9, 2018

Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only…

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 Jan 9, 2018

Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only…

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 Jan 9, 2018

Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only…

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