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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
Dec 6, 2021 Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free,... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syrin... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for I... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vi... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Dexamethasone sodium phosphate, sterile otic solution for injection Preservat... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Nov 30, 2021 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by H... Lack of sterility assurance: bag has the potential to leak. Class II Pfizer Inc.
Nov 17, 2021 Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, Fo... Lack of Assurance of Sterility Class II ASP CARES
Nov 17, 2021 Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, F... Lack of Assurance of Sterility Class II ASP CARES
Nov 17, 2021 Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, Fo... Lack of Assurance of Sterility Class II ASP CARES
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injecti... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Inje... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Inj... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injec... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx o... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave.,... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride ... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Inje... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Oct 12, 2021 TESTOSTERONE CYPIONATE 30MG/ML #1 IN ETHYL OLEATE INJECTABLE, Rx only, Talon... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/ML INJECTABLE, Rx only, Talon C... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TESTOSTERONE BI-BLEND 100/100MG/ML INJECTABLE, Rx only, Talon Compounding Ph... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021 TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.5/PGE-1 5 INJ INJECTABLE, Rx only, Tal... Lack of assurance of sterility Class II Vita Pharmacy, LLC dba Talon Compounding 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.