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Browse Drug Recalls

119 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 119 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 119 FDA drug recalls.

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DateProductReasonClassFirm
Mar 27, 2018 Lupin Cefdinir powder for Oral Suspension USP, 250 mg/5 mL in (a) 60 mL pack... Superpotent Drug Class II Lupin Pharmaceuticals Inc.
Nov 21, 2017 Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Ma... Failed Dissolution Specification Class III Lupin Pharmaceuticals Inc.
Jun 22, 2017 Paroxetine Extended-Release Tablets USP, 12.5 mg, 30 count bottle, Rx only, M... Failed Dissolution Specifications: out of specification observed in dissolution testing at 3 mon... Class III Lupin Pharmaceuticals Inc.
May 2, 2017 Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufa... CGMP Deviations Class III Lupin Pharmaceuticals Inc.
Apr 6, 2016 Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-51... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Apr 6, 2016 Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for:... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Apr 4, 2016 Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-c... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Mar 11, 2016 Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-coun... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Mar 11, 2016 Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15... CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications. Class III Lupin Pharmaceuticals Inc.
Mar 11, 2016 Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packag... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Mar 11, 2016 Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-coun... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Mar 11, 2016 Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packag... CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int... Class III Lupin Pharmaceuticals Inc.
Dec 7, 2015 Quinapril Tablets USP 5 mg, 90 count bottles, Lupin Pharmaceuticals, Inc., Ba... Failed Impurities/Degradation Specifications; Impurity A Class III Lupin Pharmaceuticals Inc.
Jan 27, 2014 Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstitute... Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... Class III Lupin Pharmaceuticals Inc.
Jan 27, 2014 Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstit... Failed Impurities/Degradation Specifications: Product did not meet specification in total impurit... Class III Lupin Pharmaceuticals Inc.
Sep 17, 2013 Quinapril Tablets USP, 5 mg, 90 count bottle, Rx only, Manufactured for: Lup... Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was fo... Class II Lupin Pharmaceuticals Inc.
Sep 17, 2013 Quinapril Tablets USP, 10 mg, 90 count bottle, Rx only, Manufactured for: Lu... Failed Impurities/Degradation Specifications: During stability testing an unknown impurity was fo... Class II Lupin Pharmaceuticals Inc.
Feb 22, 2013 Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Man... Failed Impurities/Degradation Specifications: This product is being recalled due to an out of spe... Class III Lupin Pharmaceuticals Inc.
Jan 31, 2013 Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when r... Discoloration; Product may not meet specifications for color description once reconstituted. Class III Lupin Pharmaceuticals Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.