Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE, For IM Use, Refr... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | MIC-PLEX 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 | Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE ... | 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 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML]... | 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 | 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 | Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-3... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Direct Rx |
| 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 | 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 | 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 | 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 | 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 | Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE For IV, IM Use, Refrig... | 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 | 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... |
| 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 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML]... | 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 | 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 | 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 | Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [... | 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 | 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 | Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 25... | 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 | 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 | Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM Us... | 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 | Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 15, 2020 | Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Dir... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Direct Rx |
| 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 | 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 | 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 | Cyanocobalamin Injection, CYANOCOBALAMIN 2000 MCG/ML INJECTABLE, For IV, IM... | 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 | 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 | Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE, For IV, IM ... | 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 | Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE, ... | 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 | 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 | 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 | Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE, For IV, IM ... | Lack of Assurance of Sterility | Class II | Fusion IV Pharmaceuticals, Inc. dba Axia Pharma... |
| Jan 14, 2020 | Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, ... | Subpotent: Out of specification for assay at the 12-month time point. | Class II | Pharmaceutical Associates Inc |
| Jan 14, 2020 | Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL ... | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... | Class II | Sun Pharmaceutical Industries, Inc. |
| Jan 14, 2020 | methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only... | Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to rec... | Class III | Hikma Pharmaceuticals USA Inc. |
| Jan 14, 2020 | Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp.,... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Spectrum Laboratory Products |
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.