Browse Drug Recalls
930 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 930 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 930 FDA drug recalls in 2020.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, M... | 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 | 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 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 |
| Jan 14, 2020 | Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Sin... | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... | Class II | Sun Pharmaceutical Industries, Inc. |
| Jan 10, 2020 | Estriol USP Micronized a) 100 gm NDC 62991-2159-04; b) 1 gm NDC 62991-2159-01... | Subpotent | Class II | Letco Medical LLC |
| Jan 10, 2020 | Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.0... | CGMP Deviations: Out of specification test result observed during retrospective review of blend u... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 10, 2020 | NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatat... | Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT... | Class II | Advanced Accelerator Applications USA, Inc. |
| Jan 10, 2020 | ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 430... | CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts ... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jan 7, 2020 | Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx On... | Failed Impurities/Degradation Specifications: High out of specification results for related compo... | Class II | AVKARE Inc. |
| Jan 7, 2020 | Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET W... | Microbial contamination of non-sterile product. | Class III | Sigan Industries Inc. |
| Jan 7, 2020 | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the ... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 7, 2020 | Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Appco Pharma LLC |
| Jan 7, 2020 | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the ... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 7, 2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 co... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Preferred Pharmaceuticals, Inc |
| Jan 7, 2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottl... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Preferred Pharmaceuticals, Inc |
| Jan 7, 2020 | Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Appco Pharma LLC |
| Jan 6, 2020 | Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | H J Harkins Company Inc dba Pharma Pac |
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.