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 12, 2019	Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Oxytocin 30 units in NS 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Lidocaine 1% - Sodium Bicarb 8.4% 10:1, 10 mL syringe, For Intradermal Use On...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Ph...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	DelNido Cardioplegia (Normosol-R pH 7.4 or Plasma-Lyte A pH 7.4 1000 mL bag) ...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Lidocaine 1% - Sodium Bicarbonate 8.4% 1:1, 1 mL syringe, For Intradermal Use...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Sodium Bicarbonate 150 mEq in D5W 1000 mL bags, Made by: Enterprise Pharmacy,...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	CeFAZolin 2 GM a) in NS 100 mL bag; b) 100 mg/mL (20 mL) syringe, Made by: En...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Vancomycin 2000 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Ph...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: En...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Clindamycin 900 mg in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf A...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	NICARdipine 25 mg in NS 250 mL EXCEL bag, Made by: Enterprise Pharmacy, 4400 ...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Phenylephrine 0.8 mg/10 mL NS (0.08 mg/mL), (80 mcg/mL) syringe, Made by: Ent...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Magnesium Sulfate 2 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Dexmedetomidine 400 mcg in NS 100 mL bag, Made by: Enterprise Pharmacy, 4400 ...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Magnesium Sulfate 6 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Go...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Ac...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Vancomycin 1500 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Chlorothiazide 100 mg, 3.57 mL syringe, Made by: Enterprise Pharmacy, 4400 Go...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	CeFAZolin 3 gm 100 mg/mL, 30 mL syringe, Made by: Enterprise Pharmacy, 4400 G...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Norepinephrine 16 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Gol...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Ac...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Vancomycin 1250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf ...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Lidocaine Buffered with J-Tip 0.25 mL, 1 mL syringe, 10:1, For Intradermal Us...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag, 160 mcg/mL, Made by: ...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	CefTRIAXone 1 GM, 100 mg/mL, 10 mL syringe, Made by: Enterprise Pharmacy, 440...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 12, 2019	Sodium Citrate 4%, 40 mg/mL, 3 mL syringe, Flush Syringe, Made by: Enterpris...	Lack of sterility assurance.	Class II	CMC Enterprise Pharmacy
Apr 8, 2019	Lipoplex (METHIONINE 25 MG/ML INOSITOL 50 MG/ML CHOLINE CHLORIDE 50 MG/ML HYD...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	HCG (CHORIONIC GONADOTROPIN 1000 IU/ML PEP 25 mg/mL) inj 5 mL multidose vial...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOS...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Test PROCYP (TESTOSTERONE CYPIONATE 200MG/ML TESTOSTERONE PROPIONATE 20MG/ML)...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Trimix HIGH (Papaverine HCl 30 mg/mL Phentolamine Mesylate 2 mg/mL Alprostadi...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	BPlex (METHYLCOBALAMIN 1000 MCG/ML PYRIDOXAL 5 PHOSPHATE 20MG/ML DEXPANTHENOL...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Glutathione 200mg/mL inj. a) 10 ML and b) 12 ML MULTIDOSE VIAL MDV Compounded...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	TriMix MEDIUM (Papaverine HCL 21 mg/mL Phentolamine Mesylate 0.7 mg/mL Alpros...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 8, 2019	Test D (TESTOSTERONE CYPIONATE 200MG/ML VITAMIN D3 5,000IU/ML), 5 ML MULTIDOS...	Lack of assurance of sterility for injectables and solutions intended to be sterile.	Class II	Customceutical Compounding
Apr 2, 2019	Vancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 31...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Prostaglandin Tri-Mix 8.33:22.5:0.833 Injection, 2 mL Vial, Anderson Compound...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Acetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding ...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	HCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluf...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, An...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Estradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bl...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Streptomycin 24 mg/Dexamethasone 10 mg/mL Otic Injection, 1 mL Syringe, Ander...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Gentamicin 240 mg/500 mL Sterile Water for Irrigation,60 mL Syringe, Anderson...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Prostaglandin Tri-Mix 5:15:0.5 Injection, 2 mL Vial, Anderson Compounding Pha...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, ...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Prostaglandin 40 mcg/mL, Vial, Anderson Compounding Pharmacy 310 Bluff City H...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019	Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Sali...	Lack of sterility assurance.	Class II	Anderson Compounding Pharmacy, Inc. DBA Anderso...

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.