Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 23, 2020 | BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) an... | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | Class I | CareFusion 213, LLC |
| Jun 23, 2020 | ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | Class I | CareFusion 213, LLC |
| Jun 23, 2020 | ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | Class I | CareFusion 213, LLC |
| May 11, 2020 | Sterile Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Curcumin, 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| Mar 26, 2020 | Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INN... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 26, 2020 | Testosterone Cypionate In Sesame Oil 200mg/ml, 5 mL, Injectable, Rx only, INN... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 26, 2020 | MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml) , 10 mL, ... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 26, 2020 | Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln, 5 mL, Injecta... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 26, 2020 | Methylcobalamin Soln. 1000 mcg/ml, 10 mL, Injectable, Rx only, INNOVATIVE CO... | Lack of Assurance of Sterility | Class II | Innovative Intrathecal Solutions, Inc. dba Inno... |
| Mar 19, 2020 | Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml... | Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... | Class II | Edge Pharma, LLC |
| Mar 19, 2020 | Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25... | Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for ... | Class II | Edge Pharma, LLC |
| Mar 16, 2020 | ePHEDrine Sulfate, 5 mg per mL, 50 mg per 10 mL, In 0.9% Sodium Chloride 10 ... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | HYDROmorphone in 0.9% Sodium Chloride HCl, 1 mg per mL, For IV Use, 30 mg per... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | ePHEDrine Sulfate 10 mg per mL 50 mg per 5 mL in 0.9% 5 mL Sodium Chloride ... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | rocuronium Bromide 10 mg per mL 50 mg per 5 mL, 5 mL BD Syringe, For IV Use, ... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL in 0.9% Sodium Chloride, 5 mL... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | fentaNYL Citrate Injection 50 mcg per mL, 100 mcg per 2 mL, 2 mL per syringe,... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL 5 mL syringe, Fo... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | ePHEDrine Sulfate 5 mg per mL 25 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL B... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, 5 mL BD Syringe, for IV Use... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | fentaNYL Citrate 10 mcg per mL, 2,500 mcg per 250 mL, 250 mL in a LifeCare B... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | fentaNYL Citrate 50 mcg per mL, (Preservative Free) Injection, For IV use, 1,... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | succinylcholine Chloride, 20 mg per 5 mL, 100 mg per 5 mL, 5 mL BD Syringe, F... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 16, 2020 | Gentamicin 80mg/60 mL Irrigation, containers, The Medicine Shoppe, 3524 B Tam... | Lack of Assurance of Sterility | Class II | The Medicine Shoppe Pharmacy |
| Mar 16, 2020 | nICARdipine HCl (0.1 mg/mL) 1 mg/10mL, in 0.9% Sodium Chloride Injection USP... | Firm is recalling 46 lots of various products because of a lack of sterility assurance. | Class II | PharMEDium Services, LLC |
| Mar 13, 2020 | C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Mar 13, 2020 | C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharma... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Mar 13, 2020 | *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pha... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Mar 13, 2020 | C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Me... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Mar 13, 2020 | *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Ph... | Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... | Class II | Medical Center Pharmacy, Inc. |
| Feb 27, 2020 | Elelyso (taliglucerase alfa) for injection, 200 units/vials,, Rx only, Distri... | Lack of Assurance of Sterility--Reports of loose metal ferrule crimps on vials for injection. The... | Class II | Pfizer Inc. |
| Feb 3, 2020 | Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dos... | Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects... | Class II | Pfizer Inc. |
| Jan 15, 2020 | Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE, For ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIA... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methionine/Inositol/Choline Injection, METHIONINE/INOSITOL/CHOLINE 25MG/50MG/... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCL... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/5MG/M... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE, For I... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE, For IV, IM Use, 3... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 25... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 40MCG/3... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
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.