Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Sep 3, 2019 Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, a... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all s... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle. Lack of Processing Controls: Class II Compounded Solutions in Pharmacy
Sep 3, 2019 Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all pac... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all pac... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Aug 30, 2019 Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single ... Lack of assurance of sterility. Class II Pacifico National, Inc. dba AmEx Pharmacy
Aug 30, 2019 Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single u... Lack of assurance of sterility. Class II Pacifico National, Inc. dba AmEx Pharmacy
Aug 29, 2019 Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceut... cGMP Deviations: Potential glass contamination Class II Johnson Matthey Inc.
Aug 29, 2019 Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackage... Failed Impurities/Degradation Specifications Class II Preferred Pharmaceuticals, Inc
Aug 29, 2019 Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Ma... cGMP Deviations: Potential glass contamination Class II Johnson Matthey Inc.
Aug 29, 2019 Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical ... cGMP Deviations: Potential glass contamination Class II Johnson Matthey Inc.
Aug 28, 2019 Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Sou... Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product i... Class II Atlas Pharmaceuticals, LLC
Aug 28, 2019 AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Table... Failed Stability Specifications. Class II AVKARE Inc.
Aug 24, 2019 Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UP... Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (... Class II Tuscano and Delucia Group (DBA Entropic Labs)
Aug 23, 2019 Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count carto... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Di... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, D... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Ma... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Au... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton,... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, D... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carto... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distribute... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equa... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 23, 2019 Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in... Failed Impurities/Degradation Specifications Class II Aurolife Pharma, LLC
Aug 16, 2019 Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (conce... Lack of Assurance of Sterility. Class II SCA Pharmaceuticals, LLC
Aug 14, 2019 RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 ta... Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas. Class II Pfizer Inc.
Aug 12, 2019 S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-PROCAINE HCL 1% BUFFERED MDV; Rx Only, 30ml glass vial Red Mountain Compoun... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV,... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-LIDOCAINE HCL 1% / PHENYLEPHRINE1.5% (PF) INJ SOLN, 1ml syringe, Red Mounta... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-SODIUM SELINITE 0.219% INJ, 19ml glass vials, Rx only, Red Mountain Compoun... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TRIMIX (15MG/0.5MG/10MCG/ML) INJ, Rx Only, 5ml glass vial, Red Mountain Com... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only,... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Re... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TEST CYP 125MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 10ml glass vial, Red Mo... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Com... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-MIC 25/50/50 B12A 5MG/ML MDV SOLN; Rx Only, 30ml Glass vial, Red Mountain C... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-FOLIC ACID 10MG/ML MDV INJ; packaged in 30ml glass vials, Rx Only, Red Moun... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-DMPS 50MG/ML INJ SOLN (PF), 5 ml glass vial, Rx Only, Red Mountain Compound... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25M... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compou... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-GENTAMICIN 480MG/1L, IRRIGATION SOLN, 1000ML plastic bottle, Red Mountain C... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-VITAMIN D3 10,000 IU/ML OIL MDV INJ, Rx Only, a) 5ml b) 10 ML glass vial. R... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-MAGNESIUM CHLORIDE 200MG/ML MDV INJ, 30 ml vial, Red Mountain Compounding Rx Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML glass vial, Red Mountain Compou... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2019 S-METHYLCOBALAMIN 5,000MCG/ML MDV Injection, 30 ML glass vial, Rx Only, Red M... Lack of Assurance of Sterility Class II First Royal Care Co. LLC, dba Red Mountain Comp...

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.