Browse Drug Recalls
1,788 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,788 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 1,788 FDA drug recalls in 2019.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoo... | 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 PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 ... | 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 | Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses 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 | Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, 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 | Bupivacaine HCL and Clonidine HCL and Hydromorphone 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 in all strengths, all doses and all packaging, AnazaoHealth 571... | 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 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 |
| Sep 3, 2019 | Baclofen and Morphine Sulfate 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 | Fentanyl Citrate 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 | 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 1... | Lack of Processing Controls: | Class II | Compounded Solutions in Pharmacy |
| Sep 3, 2019 | Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all st... | 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 and Bupivacaine HCL and Baclofen and Clonidine HCL in all st... | 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 and Morphine Sulfate in all strengths, all doses and all packag... | 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 and Bupivacaine HCL in all strengths, all doses and all pack... | 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 Clonidine HCL and Fentanyl Citrate in all strengths, al... | 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 and Baclofen and Clonidine HCL and Fent... | 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 Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate ... | 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 Baclofen and Clonidine HCL in all strengths, all doses ... | 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, 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 30, 2019 | Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit ... | Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerob... | Class I | Plastikon Healthcare LLC |
| 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 29, 2019 | Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical ... | cGMP Deviations: Potential glass contamination | Class II | Johnson Matthey 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 | Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackage... | Failed Impurities/Degradation Specifications | Class II | Preferred Pharmaceuticals, Inc |
| Aug 29, 2019 | Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceut... | cGMP Deviations: Potential glass contamination | Class II | Johnson Matthey Inc. |
| Aug 28, 2019 | AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Table... | Failed Stability Specifications. | Class II | AVKARE 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 27, 2019 | Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, N... | Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths secti... | Class III | American Health Packaging |
| Aug 26, 2019 | minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physici... | Failed Dissolution Specifications: | Class III | EPI Health, LLC |
| 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 | Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in... | 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 | Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distribute... | 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 | Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, D... | 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 | 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 | fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Ma... | 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 | Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Di... | Failed Impurities/Degradation Specifications | Class II | Aurolife Pharma, LLC |
| 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 21, 2019 | Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufa... | Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride... | Class III | Macleods Pharma Usa Inc |
| 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-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 1... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Co... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain... | Lack of Assurance of Sterility | Class II | First Royal Care Co. LLC, dba Red Mountain Comp... |
| Aug 12, 2019 | S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compou... | 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.