Browse Drug Recalls

66 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 66 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 66 FDA drug recalls.

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DateProductReasonClassFirm
Sep 5, 2025 Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, ... cGMP deviations: Temperature excursion during transportation. Class II Sandoz Inc
Aug 13, 2025 Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in... Temperature Abuse Class II Sandoz Inc
Aug 5, 2025 Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ... Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, cont... Class II Cardinal Health Inc.
Jun 27, 2025 Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 milli... Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labele... Class I Sandoz Inc
Jun 27, 2025 Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or ... Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vial... Class I Sandoz Inc
Apr 25, 2025 Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) an... Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02... Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 met... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Mar 21, 2022 Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Table... CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit. Class II Sandoz, Inc
Jan 26, 2022 AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automati... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Nov 17, 2021 Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Aut... Temperature Abuse; temperature excursion during shipping Class I Sandoz Inc
Oct 6, 2020 Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Sha... DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking. Class III eVenus Pharmaceutical Laboratories
Oct 17, 2019 Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to th... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Oct 17, 2019 Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Oct 17, 2019 Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx... Labeling: Incorrect or missing package insert. Class III Sandoz Inc
Sep 23, 2019 Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactur... CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... Class II Sandoz, Inc
Sep 23, 2019 Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactu... CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... Class II Sandoz, Inc
Sep 23, 2019 Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactur... CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... Class II Sandoz, Inc
Nov 7, 2018 Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60... Cross contamination with other products: Product is being recalled due to the potential presence ... Class III RemedyRepack Inc.
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufacture... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distribu... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactur... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactur... Cross Contamination with Other Products Class II Sandoz Inc
Nov 2, 2018 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bo... Cross Contamination with Other Products Class III Sandoz Inc
Nov 2, 2018 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in ... Cross Contamination with Other Products Class III Sandoz Inc
Nov 1, 2018 Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, ... CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained i... Class II Sandoz, Inc
Apr 6, 2018 Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott... Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisino... Class III Sandoz Incorporated
Sep 25, 2017 Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78... Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap ... Class III Sandoz Inc
Jun 16, 2017 Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 07... Cross Contamination With Other Product: Imipramine Class III Sandoz Incorporated
May 30, 2017 BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Onl... Failed Moisture Limits: Product tested out-of-specification for moisture content. Class III Mckesson Packaging Services
Apr 26, 2017 Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 coun... Subpotent Drug; Clavulanic Acid Class III Sandoz Inc
Feb 10, 2017 Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx o... Failed Dissolution Specifications Class II Sandoz Inc
Feb 2, 2017 Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (N... Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stat... Class II Sandoz Inc
Dec 22, 2016 Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactu... Failed dissolution specification: recalled due to an out of specification dissolution result of 4... Class II Sandoz Incorporated
Dec 13, 2016 Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC ... Subpotent Drug: out of specification results for assay test. Class III Sandoz Inc
Nov 9, 2016 L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single... Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... Class II Sandoz Inc
Nov 9, 2016 L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Packag... Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... Class II Sandoz Inc
Oct 19, 2016 Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM ... Labeling: Missing Label Class III Sandoz Inc
Aug 24, 2016 Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 6675... Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... Class II Sandoz Inc
Aug 24, 2016 Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 ... Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... Class II Sandoz Inc
Aug 24, 2016 Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pac... Defective Delivery System; reports of damaged product that may alter the predicted release of sco... Class II Sandoz Inc
May 25, 2016 Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sa... Labeling: Incorrect or Missing Package Insert Class III Sandoz Inc
Dec 31, 2015 Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) ... Failed Impurities/Degradation Specifications; 9 month stability timepoint Class III Sandoz Inc
Jul 28, 2015 Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsule... Failed Dissolution Specifications: Product is being recalled due to out of specification (above s... Class III Novartis Pharmaceuticals Corp.
Mar 9, 2015 Fomepizole Injection, 1.5 g/1.5 mL (1 g/mL), For Intravenous Infusion only, R... Lack of Assurance of Sterility. A recent FDA inspection reported GMP violations potentially impac... Class II Navinta LLC
Dec 5, 2014 Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sand... Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an i... Class III Sandoz Incorporated
Oct 2, 2014 candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactur... Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated ... Class III Sandoz, Inc
Jul 25, 2014 Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeto... Presence of Foreign Substance; tablets may contain stainless steel metal particulates Class II Sandoz Incorporated
Jul 11, 2014 Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (... Failed Dissolution Specifications: Product found to be out of specification (OOS) during stabilit... Class III Sandoz Inc
May 22, 2014 Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufa... Presence of Foreign Substance: Presence of stainless steel particles. Class II Sandoz, 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.