Browse Drug Recalls
73 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 73 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 73 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 30, 2022 | Bupivacaine HCl 150 mg (3.0 mg/mL), Ketorolac Tromethamine 60 mg (1.2 mg/mL),... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Ropivacaine HCl 123 mg (2.46 mg/mL), Clonidine HCl 0.04 mg (0.0008 mg/mL), Ke... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL) syringe, pac... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Hydromorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL), 50 mL Pre-Filled Syr... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL), Preservative Free, 5 mL... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservativ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled S... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, U... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syring... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL P... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | 8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Sy... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative F... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| May 18, 2022 | Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
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.