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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
Mar 7, 2025 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL S... Lack of Assurance of Sterility Class II Exela Pharma Sciences LLC
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/10... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/10... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Mar 6, 2025 fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/... Lack of Assurance of Sterility Class II QuVa Pharma, Inc.
Feb 18, 2025 Avastin 1.25 mg/0.05 mL in 0.25 mL Syringe, For Intravitreal Injection Only, ... Lack of Assurance of Sterility: due to a quality control process deviation. During an internal qu... Class II Turbare Manufacturing
Feb 14, 2025 BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and... Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. Class I CareFusion 213, LLC
Feb 12, 2025 ViaMed Alcohol Prep Pads, For External Use Only, 70% Isopropyl Alcohol, Steri... Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. Class II Wuxi Medical lnstrument Factory Co., Ltd.
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
Jan 31, 2025 fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single... Lack of Assurance of Sterility Class II Fagron Compounding Services
Dec 19, 2024 phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx onl... Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... Class II Hikma Injectables USA Inc
Dec 19, 2024 ketamine inj 50 mg per 1 mL, Rx Only, 1 mL fill in a 3mL pre-filled syringe, ... Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attach... Class II Hikma Injectables USA Inc
Dec 18, 2024 Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufa... Non-Sterility Class I Alcon Research LLC
Dec 10, 2024 PROFESSIONAL Regener-Eyes, Ophthalmic Solution (glycerin 0.5%) , 3mL bottles,... Lack of Sterility Assurance Class II Regenerative Processing Plant, LLC
Dec 10, 2024 LITE Regener-Eyes, Ophthalmic Solution (glycerin 0.4%), 3mL bottles, Distribu... Lack of Sterility Assurance Class II Regenerative Processing Plant, LLC
Nov 26, 2024 Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit co... Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product Class II Curium US, LLC
Nov 6, 2024 BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syr... Lack of Sterility Assurance Class II Tailstorm Health INC
Sep 16, 2024 Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye... Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Class II AbbVie Inc.
Sep 16, 2024 Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointm... Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal. Class II AbbVie Inc.
Sep 5, 2024 Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose... Lack of Assurance of Sterility Class II Empower Pharmacy
Aug 22, 2024 SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: P... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: P... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Com... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vi... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass ... Lack of Assurance of Sterility Class II ProRx LLC
Aug 22, 2024 Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, C... Lack of Assurance of Sterility Class II ProRx LLC
Aug 15, 2024 Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx o... Lack of Assurance of Sterility Class II Fagron Compounding Services
Aug 2, 2024 Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multipl... Lack of Assurance of Sterility Class II EMPOWER CLINIC SERVICES LLC
Jun 17, 2024 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assemb... Class II Baxter Healthcare Corporation
May 23, 2024 Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials... Lack of Assurance of Sterility: Leaking vials Class II Dr. Reddy's Laboratories, Inc.
May 20, 2024 Buprenorphine Hydrochloride Injection, 0.3 mg base/mL, 1 mL Single-dose Carpu... Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class II Pfizer Inc.
May 20, 2024 Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dos... Lack of Assurance of Sterility-The potential for incomplete crimp seals. Class II Pfizer Inc.
May 20, 2024 Cathflo activase (ALTEPLASE), 2mg vials, Rx only, Genentech Inc., South San F... Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo ... Class II Genentech, Inc.
May 15, 2024 EYLEA, (aflibercept) Injection, For Intravitreal injection, 2 mg (0.05mL of a... Lack of Assurance of Sterility: Complaints of syringe breakage Class II Regeneron Pharmaceuticals Inc
May 14, 2024 Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Sing... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Sing... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL... Lack of Assurance of Sterility. Class II American Regent, Inc.
May 14, 2024 Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intra... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraoc... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Pres... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, ... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
Apr 23, 2024 EYLEA, (aflibercept) Injection, 2 mg (0.05mL of a 40mg/mL solution), Single-d... Lack of Assurance of Sterility: Complaints of syringe breakage Class II Regeneron Pharmaceuticals Inc
Mar 22, 2024 Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Me... Lack of assurance of sterility: bags have the potential to leak.. Class II B. Braun Medical Inc
Mar 22, 2024 fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, I... Lack of Assurance of Sterility: leaking bags Class II IntegraDose Compounding Services LLC
Mar 6, 2024 Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec... Class II B. Braun Medical Inc
Mar 5, 2024 Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactu... Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. Class II Thea Pharma, Inc.
Feb 29, 2024 hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bot... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manuf... Lack of Assurance of Sterility Class II Optikem International, Inc.

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.