Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 26, 2022 | TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusio... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bee... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Caro... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infu... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, R... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Ca... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Car... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 B... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 26, 2022 | TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Be... | Lack of Assurance of Sterility | Class II | Carolina Infusion |
| Aug 22, 2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... | Class II | CIPLA |
| Aug 22, 2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured ... | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... | Class II | CIPLA |
| Aug 2, 2022 | Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 ... | Lack of Assurance of Sterility: Complaints received of defective container closure. | Class II | CIPLA |
| Jul 27, 2022 | Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar ... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Jul 25, 2022 | FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV b... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 25, 2022 | fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) ... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 14, 2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipl... | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... | Class II | CIPLA |
| Jun 30, 2022 | Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packag... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 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 |
| Jun 30, 2022 | Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged i... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| 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 | HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL... | 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 |
| Jun 30, 2022 | Amino Acid Injection 50 g/1000 mL (50 mg/mL) bags, Rx Only, Nephron 503B outs... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 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 |
| Jun 30, 2022 | Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged i... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | 8.4% Sodium Bicarbonate Injection, USP, 4.2 g/50 mL (84 mg/mL) 1 mEq/mL syrin... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packag... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | 0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, p... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | HYDROmorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL) syringes, 5 x 30 mL ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL) syringes, packaged in ... | 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 | Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL) syringe, packaged in 5 x 4... | 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.