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 12, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 10... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Us... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 10... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only,... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 1... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free)... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single D... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL)... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnolog... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syr... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 9, 2019 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, ... | Failed Impurities/Degradation Specificattion | Class II | West-Ward Columbus Inc |
| Sep 6, 2019 | Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hosp... | Lack of Assurance of Sterility | Class II | Pfizer Inc. |
| Sep 6, 2019 | Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in... | Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities de... | Class II | Torrent Pharma Inc. |
| Sep 6, 2019 | Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For... | Temperature Abuse; Product stored and shipped outside of labeled storage requirements. | Class II | Cardinal Health dba Specialty Pharmaceutical Se... |
| Sep 4, 2019 | Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count... | CGMP Deviation: Presence of dark brown discoloration on edges of tablets. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Sep 3, 2019 | Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all dose... | 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 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 | Clonidine HCL and Baclofen in all strengths, all doses and all packaging, Ana... | 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 in all strengths, all doses and all packa... | 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 | Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL P... | 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 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 | 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml drop... | Lack of Processing Controls: | Class II | Compounded Solutions in Pharmacy |
| Sep 3, 2019 | Clonidine HCL and Baclofen and Fentanyl Citrate 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 | 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 |
| 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 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 | 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 | 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 | 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 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 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 |
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.