Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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. |
| 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 | Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE, For ... | 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 | Selenium Injection, SELENIUM 200MCG/ML INJECTABLE, For IV Use, 30 mL Multi-d... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ S... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable, For IV,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For... | 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 | Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Super MIC Injection, SUPER MIC* INJECTABLE, Vitamin Complex, For IM Use, 30 ... | 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 | Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIA... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil (prostaglandin E1) 80 MCG/ML Injectable, For Intracavernosal Use,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable, For IV,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML]... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil (prostaglandin E1)150 MCG/ML Injectable, For Intracavernosal Use,... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE, For IV Use, 30 ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, M... | 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 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 20MCG/3... | 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 | Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, M... | 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 | Deoxycholic Acid Sodium Injection,DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE, F... | 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 | Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE, For... | 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 | Calcium Chloride Injection, For IM Use, Refrigerate, Shake Well, 30 mL Multi-... | 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... |
| 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 | Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE, For IV, IM, SC... | 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 | Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Sh... | 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 | Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABL... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | B-COMPLEX 110 INJECTABLE, For IV, IM, SC Use, Refrigerate, 30 mL Multi-dose ... | 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 | Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTAB... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate I... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Glycine Injection,GLYCINE USP 50MG/ML INJECTABLE, For IV, IM Use,30 mL Mult... | 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.