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 |
|---|---|---|---|---|
| Nov 18, 2016 | Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Sing... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syr... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 1... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syri... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), S... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Sing... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 17, 2016 | TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compo... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chlo... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML). Compounded by Tri-Coast ... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Glucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocai... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/m... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 ... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tr... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calci... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Met... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast ... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg)... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/2mg/30mg/mL, (1 ML). Compo... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Vitamin D3 100,000 Unit/mL, in olive oil, (30 ML). Compounded by Tri-Coast P... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Sermorelin Forte Plus 27 mg (Sermorelin Acetate 9 mg/GHRP-6 9 mg/GHRP-2 9 mg)... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calci... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Com... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compo... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/30mg/mL, (1 ML). Compo... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/1mg/30mg/mL, (1 ML). Compo... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | HCG/Hydroxycobalamin 5,000 IU/5 mg Vial. Compounded by Tri-Coast Pharmacy | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compo... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL, (1 ML). Compo... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). ... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
| Nov 17, 2016 | Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25m... | Lack of Assurance of Sterility | Class II | Tri-Coast Pharmacy |
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.