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Browse Drug Recalls

1,301 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,301 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 1,301 FDA drug recalls in IL.

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DateProductReasonClassFirm
Oct 13, 2022 Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bo... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 m... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx O... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufa... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, U... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, R... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reli... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manu... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tub... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Olopatadine HCl Ophthalmic Solution, USP 0.2%, 2.5 mL per bottle, Rx Only, Ma... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per dropper bottle, Rx Only, ... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Packaged as a) 10 mL droppe... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufacture... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 GONAK Hypromellose Ophthalmic Demulcent Solution, (25 mg) 2.5%, 15 mL per dro... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactur... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Packaged as (a) 5 mL tube (NDC 17478-7... CGMP Deviations: Class II Akorn, Inc.
Oct 13, 2022 Tobramycin Ophthalmic Solution, USP, 0.3%, 5 mL per bottle, Rx Only, Manufact... CGMP Deviations: Class II Akorn, Inc.
Sep 21, 2022 Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Akorn, Inc.
Sep 21, 2022 Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Distributed by: Ako... Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit fo... Class II Akorn, Inc.
Aug 31, 2022 Sodium Chloride Ophthalmic Ointment USP, 5%, Sterile, Net Wt 3.5 g (1/8 oz) t... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 31, 2022 Lidocaine Hydrochloride Jelly USP, 2%, Sterile, 30mL tube, Rx only, Manufact... cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scop... Class II Akorn, Inc.
Aug 8, 2022 Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials,... Identification of an unknown impurity at the 12-month stability point. Further investigation has ... Class III Akorn, Inc
Aug 4, 2022 Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container b... Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets ind... Class II Baxter Healthcare Corporation
Aug 1, 2022 PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TE... Defective Container: Product has incomplete induction seals. Class II Akorn, Inc
Jun 13, 2022 Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amb... Defective container: defect prevents product from dispensing as intended. Class II Akorn, Inc.
Jun 10, 2022 Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl... Defective Delivery System: Potential defect that could prevent the product from dispensing as int... Class II Akorn, Inc.
Jun 3, 2022 Olopatadine HCl, Ophthalmic Solution, USP, 0.2%, 2.5 mL per dropper bottle, R... Failed impurity/degradation specifications: Out of specification for 2-HMP (a product leachable) ... Class III Akorn, Inc.
Apr 15, 2022 Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per b... Failed viscosity specification - product was below specificcation Class III Akorn, Inc.
Apr 1, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit ... Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Apr 1, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit ... Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Im... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Mar 4, 2022 Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 t... Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts o... Class I Fresenius Kabi USA, LLC
Feb 21, 2022 Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only,... Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impuritie... Class II Morton Grove Pharmaceuticals, Inc.
Jan 5, 2022 Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous an... Subpotent Drug: Out of specification for assay at the 30-month stability timepoint. Class II Akorn, Inc.
Dec 3, 2021 Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bo... Labeling: Missing Label Class III Akorn, Inc.
Dec 3, 2021 Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx o... Labeling: Missing Label Class III Akorn, Inc.
Nov 17, 2021 Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aero... Chemical contamination: Presence of benzene Class I Blistex Inc
Nov 8, 2021 Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, ND... Defective Container: Customer complaints for leaking bottles and dispensing issues. Class II Medline Industries Inc
Nov 1, 2021 Acetaminophen Oral Suspension, 160 mg/5 mL, packaged in 5 mL per cup (NDC Ind... cGMP Deviations: Product manufactured with contaminated raw ingredient. Class II Precision Dose Inc.
Nov 1, 2021 Acetaminophen Oral Suspension, 325 mg/10.15 mL, packaged in 10.15 mL per cup... cGMP Deviations: Product manufactured with contaminated raw ingredient. Class II Precision Dose Inc.
Oct 5, 2021 Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S... Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it ... Class III A-S Medication Solutions LLC.
Oct 4, 2021 Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dro... Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stabil... Class II Akorn, Inc.
Sep 17, 2021 Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only,... Defective container: Cracked vials leading to lack of sterility assurance Class II Fresenius Kabi USA LLC
Sep 8, 2021 TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 3... Lack of Assurance of Sterility Class II Akorn, 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.