Browse Drug Recalls

6,228 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,228 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 6,228 FDA drug recalls.

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Date	Product	Reason	Class	Firm
Apr 2, 2019	HCG 11,00Units/B 12 11,000 mcg Injection, 30 mL Vial, Anderson Compounding Ph...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Polyhexamethylene Biguanide 0.02% Ophthalmic Drops, 2 mL Dropper, Anderson Co...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 m...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff ...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Gentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy ...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Mar 13, 2019	Glycopyrrolate Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single ...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	fentaNYL 2500 mcg/250 mL Injectable Solution, Fentanyl 0.9% Sodium Chloride, ...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Glycopyrrolate 0.6 mg/3 mL (0.2 mg per mL) Injectable Solution, 3 mL Sterile ...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Sol...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Morphine Sulfate 30 mg/30 mL (1 mg/mL) Injectable Solution Morphine Sulfate 3...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Ster...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Heparin 5,000 Units/5mL (1,000 Units per mL) Injectable Solution, 5,000 Units...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Phenylephrine HCl, 400 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solut...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectabl...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Phenylephrine HCl, 1 mg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride, Q...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable Soluti...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	2% Lidocaine HCl Injectable Solution, 60 mg/3 mL (20 mg per mL), 3mL Sterile ...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	2% Lidocaine HCl Injectable Solution, 100 mg/5 mL (20 mg per mL), 5mL Sterile...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Phenylephrine HCl, 1 mg in Sterile Water for Injection, QS 10 mL Injectable S...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 13, 2019	Esmolol HCl Injectable Solution 100 mg/10 mL (10 mg per mL)10mL Sterile singl...	Lack of Assurance of Sterility	Class II	Advanced Pharma Inc.
Mar 12, 2019	Dr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr...	Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.	Class II	MSM Nutraceuticals, LLC
Mar 12, 2019	Dry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Aci...	Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.	Class II	MSM Nutraceuticals, LLC
Mar 12, 2019	Red Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Aci...	Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.	Class II	MSM Nutraceuticals, LLC
Mar 12, 2019	15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceutic...	Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.	Class II	MSM Nutraceuticals, LLC
Mar 11, 2019	Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx ...	Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, there...	Class II	Iso-Tex Diagnostics, Inc
Mar 6, 2019	Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx onl...	Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterilit...	Class II	Dr. Reddy's Laboratories, Inc.
Jan 29, 2019	Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compoun...	Lack of assurance of sterility.	Class II	US Compounding Inc
Jan 24, 2019	BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distr...	Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.	Class II	Sun Pharmaceutical Industries, Inc.
Jan 2, 2019	Glutathione liquid, 100mg/ml	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Glutathione liquid, 200mg/ml, Rx	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, ...	Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle	Class II	Heritage Pharmaceuticals, Inc.
Jan 2, 2019	Cyclosporin liquid 0.5%, Rx, plastic dropper bottle	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Cyclosporin liquid 1%, Rx, plastic dropper bottle	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Lidocaine gel 1%, RX, plastic dropper	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Methocarbamol liquid 100mg/ml, RX, glass vial	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Lidocaine/Epinepherine liquid 1%/ 1:1000, RX, glass vial These include inj...	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Cyclosporin liquid 0.05%, Rx, plastic dropper bottle	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Hydroxyprogesterone liquid, 250mg/ml, RX, glass vial	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Lidocaine gel 2%, RX, plastic dropper	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Cyclosporin liquid 2%, Rx, plastic dropper bottle, dry eye	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Cyclosporin liquid 0.2%, Rx, plastic dropper bottle	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	HCG liquid, 1000u/ml, RX, glass vial, various	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Testosteron Cypionate liquid 200mg/ml, RX, glass vial	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Epinephrine liquid 1:1000, RX, glass vial	Lack of sterility assurance.	Class II	Hiers Enterprises, LLC dba Northwest Compoundin...
Jan 2, 2019	Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro...	Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.	Class II	Baxter Healthcare Corporation

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.