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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.