Browse Drug Recalls

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

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Date	Product	Reason	Class	Firm
Mar 23, 2016	PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. ...	Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ...	Class II	Akorn, Inc.
Mar 23, 2016	Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ...	Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.	Class I	Hospira Inc.
Mar 23, 2016	ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (47...	Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) ...	Class II	Akorn, Inc.
Mar 23, 2016	Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per ca...	Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were...	Class II	TMIG Inc
Mar 23, 2016	Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ...	Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.	Class III	Hospira Inc.
Mar 18, 2016	8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL),...	Presence of Particulate Matter: particulate matter identified as an insect in one vial.	Class I	Hospira Inc.
Mar 17, 2016	Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distribu...	Labeling: Incorrect or Missing Lot and/or Exp. Date	Class III	Impax Laboratories, Inc.
Mar 17, 2016	Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distribu...	Labeling: Incorrect or Missing Lot and/or Exp. Date	Class III	Impax Laboratories, Inc.
Mar 16, 2016	Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL...	Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-sp...	Class III	Actavis Pharma Inc
Mar 15, 2016	Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL ...	Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiratio...	Class III	Hospira Inc.
Mar 14, 2016	Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratori...	Lack of Assurance of Sterility: incomplete or missing data regarding production.	Class II	Meditech Laboratories, Inc
Mar 14, 2016	Formula 4 (Papaverine 18 mg, Phentolamine 2 mg, Atropine 0.2 mg/mL) Injection...	Lack of Assurance of Sterility: incomplete or missing data regarding production.	Class II	Meditech Laboratories, Inc
Mar 14, 2016	Formula 9 (Papaverine 0.9 mg, Phentolamine 0.1 mg, Atropine 0.01 mg, PGE 20 m...	Lack of Assurance of Sterility: incomplete or missing data regarding production.	Class II	Meditech Laboratories, Inc
Mar 14, 2016	Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manu...	Failed Impurities/Degradation Specifications	Class II	Impax Laboratories, Inc.
Mar 14, 2016	Formula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/m...	Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the...	Class II	Meditech Laboratories, Inc
Mar 14, 2016	Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manuf...	Failed Impurities/Degradation Specifications	Class II	Impax Laboratories, Inc.
Mar 14, 2016	Formula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 m...	Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the...	Class II	Meditech Laboratories, Inc
Mar 14, 2016	Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL...	Superpotent Drug: one ingredient was found to be above assay specification.	Class II	Meditech Laboratories, Inc
Mar 14, 2016	Formula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL...	Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the...	Class II	Meditech Laboratories, 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.
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	SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by J...	Labeling: Label Error on Declared Strength	Class III	Jubilant Draximage 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 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, 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 9, 2016	Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manu...	Presence of Particulate Matter: particulate matter identified as glass in one vial.	Class I	Teva Pharmaceuticals USA
Mar 8, 2016	Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Ho...	Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ...	Class II	Hospira Inc.
Mar 8, 2016	Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hos...	Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ...	Class II	Hospira Inc.
Mar 8, 2016	Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hos...	Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ...	Class II	Hospira Inc.
Mar 8, 2016	Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Ho...	Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ...	Class II	Hospira Inc.
Mar 8, 2016	Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx on...	Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ...	Class II	Hospira Inc.
Mar 8, 2016	Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, In...	Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon ...	Class II	Hospira Inc.
Mar 3, 2016	Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL), 100 mL Single Use Bottle...	Lack of Assurance of Sterility; defective seals where the metal silver ring was not attached tigh...	Class II	Dr. Reddy's Laboratories, Inc.
Mar 1, 2016	Fluconazole Injection, USP (in 0.9% Sodium Chloride), 200 mg per 100 ml, Sing...	Cross contamination with other products: metronidazole	Class II	Sagent Pharmaceuticals Inc
Feb 29, 2016	col-rite (docusate sodium) stool softener softgels, 50 mg, packaged in a) 30-...	Superpotent Drug: High out of specification results for assay at the 6 month time point interval.	Class III	Allegiant Health
Feb 25, 2016	Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per car...	Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as...	Class III	Torrent Pharmaceuticals Limited
Feb 19, 2016	Amlodipine Besylate Tablets USP, 2.5mg, 90-count bottles, Rx only, Manufactur...	CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int...	Class III	Lupin Limited
Feb 19, 2016	Amlodipine Besylate Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactu...	CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose int...	Class III	Lupin Limited
Feb 16, 2016	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Failed Impurities/Degradation Specifications: Out of specification for impurities.	Class II	Actavis Elizabeth LLC
Feb 16, 2016	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Failed Impurities/Degradation Specifications: Out of specification for impurities.	Class II	Actavis Elizabeth LLC
Feb 16, 2016	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Failed Impurities/Degradation Specifications: Out of specification for impurities.	Class II	Actavis Elizabeth LLC
Feb 16, 2016	Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat...	Failed Impurities/Degradation Specifications: Out of specification for impurities.	Class II	Actavis Elizabeth LLC
Feb 16, 2016	Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, Fo...	Presence of Particulate Matter: Glass particles found in the product after reconstitution.	Class II	Genzyme Corporation
Feb 16, 2016	Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, Fo...	Presence of Particulate Matter: Glass particles found in the product after reconstitution.	Class II	Genzyme Corporation
Feb 12, 2016	Paliperidone Extended-release Tablets, 1.5 mg, 30 count bottles, Rx only, Myl...	Failed Dissolution Specifications; three month stability time point.	Class II	Mylan Pharmaceuticals Inc.
Feb 12, 2016	Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N ...	Lack of Assurance of Sterility	Class II	Walter's Pharmacy
Feb 12, 2016	Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, ...	Lack of Assurance of Sterility	Class II	Walter's Pharmacy
Feb 12, 2016	Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bo...	Lack of Assurance of Sterility	Class II	Walter's Pharmacy
Feb 12, 2016	Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N ...	Lack of Assurance of Sterility	Class II	Walter's Pharmacy
Feb 12, 2016	Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only,...	Lack of Assurance of Sterility	Class II	Walter's Pharmacy

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.