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Browse Drug Recalls

607 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 607 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 607 FDA drug recalls in OH.

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DateProductReasonClassFirm
Mar 15, 2021 Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containi... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 15, 2021 Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Mar 9, 2021 Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe ... Temperature Abuse Class III Cardinal Health Inc.
Jan 7, 2021 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per cart... Failed Dissolution Specifications Class II American Health Packaging
Oct 21, 2020 Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 1... CGMP Deviations Class II H & H Remedies, LLC
Oct 21, 2020 White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold... CGMP Deviations Class II H & H Remedies, LLC
Oct 21, 2020 Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. M... CGMP Deviations Class II H & H Remedies, LLC
Jul 22, 2020 Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr.... Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. Class III West-Ward Columbus Inc
Jul 1, 2020 Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), F... Microbial contamination of non-sterile products: positive microbial contamination in product. Class I Spartan Chemical Co Inc
Jun 10, 2020 Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blis... Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medi... Class III American Health Packaging
May 19, 2020 Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx ... Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month tim... Class II American Health Packaging
May 13, 2020 Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. b... Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degra... Class III West-Ward Columbus Inc
May 13, 2020 Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC ... Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf l... Class II West-Ward Columbus Inc
Feb 7, 2020 Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister ca... GMP Deviations: Product bottle may be absent of desiccant. Class II American Health Packaging
Feb 7, 2020 Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister ca... GMP Deviations: Product bottle may be absent of desiccant. Class II American Health Packaging
Dec 4, 2019 Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... Failed Dissolution Specifications: Low out of specification results obtained during stability tes... Class II American Health Packaging
Nov 20, 2019 Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), ... CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... Class II American Health Packaging
Nov 1, 2019 Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per c... CGMP Deviations: Presence of NDMA impurity detected in product. Class II American Health Packaging
Sep 9, 2019 Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, ... Failed Impurities/Degradation Specificattion Class II West-Ward Columbus Inc
Aug 27, 2019 Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, N... Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths secti... Class III American Health Packaging
Aug 9, 2019 Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister c... Failed Dissolution Specifications Class II American Health Packaging
Aug 8, 2019 Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed... Class II Alkermes Inc
Jun 19, 2019 EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE, 100 ML per vial, RXQ Compoundin... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 NEOSTIGMINE METHYL SULFATE 1MG/ML INJ SOL SYR, 5 ML per syringe, RXQ Compound... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 ONDANSETRON 2 MG/ML INJECTION SOLUTION (NPF), 20ML per vial, RXQ Compounding,... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 CYANCOBALAMIN 1200MCG/ML MDV INJECTION, 30 ML per vial, RXQ Compounding, 340 ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MAGNESIUM 200 MG/ML/ CALCIUM GLUC 6MG/ML/ ZINC 1MG/ML, 5ML per vial, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Ascorbic Acid 500 MG/ML (Non-Corn) Injection (PFV), 50 mL per vial, RXQ Compo... Crystallization Class II RXQ Compounding LLC
Jun 19, 2019 ROPIVICAINE 0.2%, INJ SOLN, 550 ML ON-Q PUMP. RXQ Compounding, 340 West State... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SOL SYR (C-IV), 10 ML per syringe, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Inositol/Choline B12:B6, 50/50/1/0.175 MG/ML INJ SOLN(Sulfa Free Lipostat), 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SYR C-IV, 55 ML per syringe, RXQ Compoundin... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR, 1 ML PER Syringe, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 RXQ CAIN (PHENYLEP 1.5%/ LIDO 1% OPHTH SOL (PF), 1 ML PER VIAL, RXQ Compoundi... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MITOMYCIN 0.04% (PF) OPH SOLN, 1ML per syringe, RXQ Compounding, 340 West Sta... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 KETAMINE 50 MG/ML (NPV) INJECTION SOLUTION (C-III), 10 ML per vial, RXQ Compo... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 LIDOCAINE HCL 1% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 DIMERCAPTO-PROPANESULFONIC 5% (DMPS)( (PFV) INJ SOL, 5 ML per vial, RXQ Compo... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Ascorbic Acid 400 MG/ML (Non-Corn) Injection Solution, 65 mL per vial, RXQ Co... Crystallization Class II RXQ Compounding LLC
Jun 19, 2019 STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Ascorbic Acid 500 MG/ML (Non-Corn) INJ (MDV), 50 mL per vial, RXQ Compounding... Crystallization Class II RXQ Compounding LLC
Jun 19, 2019 PROCAINE HCL 20 MG/ML (MDV) INJECTABLE SOLUTION, 30 ML per vial. RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 POTASSIUM CHLORIDE 15% (2MEQ/ML) INJ SOLN, 30 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EDETATE DISODIUM 15% INJECTABLE, 30 ML per vial, RXQ Compounding, 340 West St... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIC (METHIONINE/INOSITOL/CHOLINE CHLORIDE) 25/50/50 MG/ML INJ, 30 ML per vial... Lack of Assurance of Sterility Class II RXQ Compounding LLC

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.