Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Dec 28, 2020 Levetiracetam Oral Solution, 100 mg/mL, 16 fl oz (473 mL) bottle, Rx Only, HI... Defective container: Customer complaints for oral solution leaking from bottles. Class II Akorn, Inc.
Dec 28, 2020 Paroex (Chlorhexidine Gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only... cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia... Class II Sunstar Americas, Inc.
Dec 23, 2020 IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 3.4 fl. oz. (100 ml), Mad... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II Shane Erickson Inc
Dec 23, 2020 IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 1.7 fl. oz. (50 ml) bottl... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II Shane Erickson Inc
Dec 23, 2020 IMC Wash-Free Hand Sanitizer, (ethyl alcohol), 75%, 10.1 fl. oz. (300 ml), Ma... CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled... Class II Shane Erickson Inc
Dec 21, 2020 Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose... Lack of assurance of sterility: The results of sterility tests of seven batches of product were o... Class II Merck Sharp & Dohme
Dec 17, 2020 PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection, CII, Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 ePHEDrine Sulfate 50 mg/10mL in 0.9% Sodium Chloride Injection, 10 mL Single ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL ... Failed Impurity/Degradation Specifications Class II Ascend Laboratories LLC
Dec 17, 2020 fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 5... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9% (100 mcg/mL) Rx Only,... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 fentaNYL 1500 mcg/30 mL (50 mcg/mL), 30 mL Single Dose Syringe, Rx Only, SCA ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection, Rx Only, 5 mL Single ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 fentaNYL 100 mcg/50mL Ropivacaine HCl 0.1% in 0.9% Sodium Chloride 50 mL, 50 ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx On... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmace... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Sing... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), R... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL ... Failed Impurity/Degradation Specifications Class II Ascend Laboratories LLC
Dec 17, 2020 Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... Presence of Particulate Matter - found in reserve sample vials at the firm. Class II Fresenius Kabi USA, LLC
Dec 17, 2020 Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in ... Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... Class II CIPLA
Dec 17, 2020 SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA P... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 ePHEDrine Sulfate, 50 mg/5mL in 0.9% Sodium Chloride Injection, 5 mL Single D... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Esmolol HCl 100 mg/10 mL (10mg/ mL), 10 mL Single Dose Syringe, Rx Only, SCA... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syr... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Lidocaine HCl 1% 10 mL (10mg/ml), Rx Only, 1 mL Single Dose Syringe, SCA Pha... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in ... Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... Class II CIPLA
Dec 17, 2020 fentaNYL 100 mcg/2mL Injection for IV or IM Use, 2 mL Single Dose Syringe, CI... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Glycopyrrolate 1 mg/5mL (0.2mg/mL), 5 mL Single Dose Syringe, Rx Only, SCA P... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1m... Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. Class II Imprimis NJOF, LLC
Dec 17, 2020 labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 HYDROmorphone HCl 6 mg/30mL in 0.9% Sodium Chloride Injection (0.2 mg/mL), Rx... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection ... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dos... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(bar... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in ... Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... Class II CIPLA
Dec 17, 2020 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride (80 mcg/mL), Rx Only,... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Onl... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 17, 2020 Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only... Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... Class II SCA Pharmaceuticals
Dec 14, 2020 Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use On... cGMP deviations: Vials may not be sealed correctly affecting sterility. Class II CIPLA
Dec 14, 2020 Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dos... Subpotent drug. Class II SCA Pharmaceuticals, Inc.
Dec 10, 2020 Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 m... Subpotent Drug: Low out-of-specification assay results for the epinephrine component. Class II Fresenius Kabi USA, LLC
Dec 9, 2020 Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in... Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, ... Class II Morton Grove Pharmaceuticals, Inc.
Dec 9, 2020 Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufac... CGMP Deviations Class II Akebia Therapeutics dba Keryx Biopharmaceutials...
Dec 9, 2020 Vumerity (diroximel fumarate) delayed-release capsule, 231 mg, packaged in a... Failed dissolution specifications: out-of-specification test results observed during the buffer s... Class II Biogen MA 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.