Browse Drug Recalls

695 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 695 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 695 FDA drug recalls in PA.

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Date	Product	Reason	Class	Firm
Nov 12, 2015	DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFAT...	Failed Impurities/Degradation Specifications: High out of specification test result for impuritie...	Class II	Teva Pharmaceuticals USA
Nov 11, 2015	Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Ind...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, ...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutiona...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Ba...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, R...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Instituti...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Nov 11, 2015	Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma In...	Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due...	Class II	RemedyRepack Inc.
Oct 30, 2015	Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor ...	Failed Impurities/Degradation Specifications: Out of specifications results for impurities.	Class III	Avantor Performance Materials Inc
Oct 9, 2015	Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH...	Presence of foreign substance -This recall has been intiated due to the presence of a polyethylen...	Class II	Mutual Pharmaceutical Company, Inc.
Aug 6, 2015	LiDa DAIDAIHUA (also packaged as LiDa DAIDAIHUAJIAONANG), capsules, packaged ...	Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.	Class I	Blue Square Market, Inc.
Aug 6, 2015	KABOOM action strips, Sexual Performance Strips, packaged in 6.4oz box 12 str...	Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.	Class I	Blue Square Market, Inc.
Jul 24, 2015	ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x...	Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution	Class I	Teva Pharmaceuticals USA
Jul 16, 2015	Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutua...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmac...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmac...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutu...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutua...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 16, 2015	Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutu...	Chemical Contamination; benzophenone leached from the product label varnish	Class III	Mutual Pharmaceutical Company, Inc.
Jul 15, 2015	SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0...	Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth...	Class II	GlaxoSmithkline Consmer Healthcare
Jul 15, 2015	biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (1...	Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth...	Class II	GlaxoSmithkline Consmer Healthcare
Jul 15, 2015	biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, Sou...	Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth...	Class II	GlaxoSmithkline Consmer Healthcare
Jul 15, 2015	biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tub...	Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth...	Class II	GlaxoSmithkline Consmer Healthcare
Jul 15, 2015	biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 ...	Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth...	Class II	GlaxoSmithkline Consmer Healthcare
Jul 15, 2015	SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech...	Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth...	Class II	GlaxoSmithkline Consmer Healthcare
Jul 15, 2015	SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufacture...	Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth...	Class II	GlaxoSmithkline Consmer Healthcare
Jul 15, 2015	SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured ...	Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth...	Class II	GlaxoSmithkline Consmer Healthcare
Jul 14, 2015	Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bott...	Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown...	Class III	KVK-Tech, Inc.
Jul 9, 2015	Clonidine Hydrochloride Tablets, USP, 0.2 mg, packaged in a) 100 count (NDC 5...	cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product...	Class II	Mutual Pharmaceutical Company, Inc.
Jul 9, 2015	Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 5...	cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product...	Class II	Mutual Pharmaceutical Company, Inc.
Jul 9, 2015	Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100 count HDPE bottles, Rx only...	cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product...	Class II	Mutual Pharmaceutical Company, Inc.
Jun 30, 2015	Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-9...	Failed Dissolution Specifications	Class III	GlaxoSmithkline Consmer Healthcare
Jun 30, 2015	Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceu...	Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were ob...	Class II	Mylan Pharmaceuticals Inc
Jun 24, 2015	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Failed Impurities/Degradation Specifications: out of specification for unknown impurity	Class II	Teva Pharmaceuticals USA
May 20, 2015	Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only,...	Failed Dissolution Specifications: Low out of specification dissolution results.	Class II	Mylan Lab Inc
May 11, 2015	Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manuf...	Failed Dissolution Specifications: OOS result during stability testing	Class II	Teva Pharmaceuticals USA
May 7, 2015	QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For...	Failed Impurities/Degradation Specifications: out of specification test results for an impurity d...	Class III	Teva Pharmaceuticals USA
Apr 28, 2015	Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct In...	Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone ...	Class I	Teva Pharmaceuticals USA
Apr 23, 2015	KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside ...	Crystallization	Class II	RemedyRepack Inc.
Apr 13, 2015	Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured b...	Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ...	Class II	Teva Pharmaceuticals USA
Apr 13, 2015	Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-6...	Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ...	Class II	Teva Pharmaceuticals USA
Mar 10, 2015	Ergoloid Mesylates ,1 mg tablets, 100 count bottle, Rx only, Manufactured by...	Failed Impurities/Degradation Specifications: during long-term stability testing.	Class II	Mutual Pharmaceutical Company, Inc.
Feb 18, 2015	KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside...	Crystallization	Class II	RemedyRepack Inc.
Dec 17, 2014	Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% without Ca, Trophamine 12g, ...	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Class I	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	Truman Medical Center Lakewood (MO) Trophamine UAC Solution, Trophamine 3.2g,...	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Class I	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	Robert Wood Johnson University (NJ) Neonatal Starter 10% Dextrose, Trophamine...	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Class I	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	Walter Reed Natl Mil Med Ctr (MD) Stock TPN D10% with Ca, Trophamine 12g, Dex...	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Class I	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	St Lukes East Lees Summit (MO) Protein Bag,Trophamine 5g, Dextrose 10%, Addit...	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Class I	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	Lankenau Hospital (PA) TPN Neonatal Starter Bag, Trophamine 2.5%, Dextrose 10...	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Class I	Central Admixture Pharmacy Services, Inc.
Dec 17, 2014	Robert Wood Johnson University (NJ) Neonatal Starter 5% Dextrose, Trophamine ...	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Class I	Central Admixture Pharmacy Services, 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.