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 |
|---|---|---|---|---|
| Sep 12, 2019 | GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx O... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Sing... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropic... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, ... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartr... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Us... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Gl... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Sing... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite F... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.01... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Ca... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechno... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global B... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made... | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... | Class III | Pfizer Inc. |
| Sep 12, 2019 | Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Sy... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS G... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 2... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KR... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxin... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx On... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropic... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 10... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Us... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 10... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only,... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 1... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free)... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 9, 2019 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, ... | Failed Impurities/Degradation Specificattion | Class II | West-Ward Columbus Inc |
| Sep 6, 2019 | Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: ... | Failed Impurities/Degradation Specifications:OOS for unknown impurity. | Class III | Mylan Pharmaceuticals Inc. |
| Sep 6, 2019 | Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hosp... | Lack of Assurance of Sterility | Class II | Pfizer Inc. |
| Sep 6, 2019 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 coun... | GMP Deviation: lot not intended for commercial distribution. | Class III | Teva Pharmaceuticals USA |
| Sep 6, 2019 | Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in... | Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities de... | Class II | Torrent Pharma Inc. |
| Sep 6, 2019 | Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g N... | Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified a... | Class I | Darmerica, LLC |
| Sep 6, 2019 | Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For... | Temperature Abuse; Product stored and shipped outside of labeled storage requirements. | Class II | Cardinal Health dba Specialty Pharmaceutical Se... |
| Sep 4, 2019 | Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count... | CGMP Deviation: Presence of dark brown discoloration on edges of tablets. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
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.