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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-... 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 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 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
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 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 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 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 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 Ketamine HCl Injection, USP, 50 mg/5 mL (10 mg/mL*) syringes, packaged in 5 x... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jun 30, 2022 Morphine Sulfate Injection, USP, 1 mg/mL syringe, packaged in 5 x 1 mL Pre-Fi... 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 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 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 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 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 16, 2022 Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregat... Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing. Class II Jubilant Draximage Inc
Jun 10, 2022 Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial exc... Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 24, 2022 B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HC... Lack of Assurance of Sterility Class II US Specialty Formulations LLC
May 24, 2022 Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formu... Lack of Assurance of Sterility Class II US Specialty Formulations 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 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 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 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
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 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 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 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 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 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 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, 0.4 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 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 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 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 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 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 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 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 9, 2022 T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Package... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx ... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Dexpanthenol 250 mg/mL Multi-Dose 30 mL Rx Only, Olympia Pharmaceuticals, 670... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022 Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 m... Lack of assurance of sterility. Class II Olympia Compounding Pharmacy dba Olympia 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.