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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.

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DateProductReasonClassFirm
Feb 10, 2025 Sodium Chloride Injection 9%, USP, 500 mL, Single-Dose IV Bottle, Rx Only, ne... Lack of Assurance of Sterility: There is a potential for leakage at the IV bottle port. Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 m... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 m... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Jan 6, 2023 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syri... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Nov 10, 2022 PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 5... CGMP Deviations: Potential for cross contamination due to product carry over. Class II Nephron Sterile Compounding Center LLC
Nov 10, 2022 PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only... CGMP Deviations: Potential for cross contamination due to product carry over. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mm... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL ... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Via... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. Class II Nephron Sterile Compounding Center LLC
Aug 10, 2022 PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Un... CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. 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 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 0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL... 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 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 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 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 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 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 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 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 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 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, 50 mg/50 mL (1 mg/mL) syringes, packaged in... 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 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 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 HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre... 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 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 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 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 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 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 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 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 Neostigmine Methylsulfate Injection, USP, 4 mg/4 mL (1 mg/mL) syringe, packag... 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 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, 30 mg/30 mL (1 mg/mL) syringe, packaged in 5... 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

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.