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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

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DateProductReasonClassFirm
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 20MG/2MG/20MCG/ML, packaged in a) 5 mL and b) 10 mL vial... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-UREA 40% BLADDER INSTILL, 30 mL vial, Rx only, Colonia Care Pharmacy, 515 I... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 18MG/0.6MG/5.88MCG/ML, 5 mL vial, Rx only, Colonia Care ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 30MG/2MG/20MCG/ML, 5 mL vial, Rx only, Colonia Care Phar... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-VERAPAMIL 2.5MG/ML INJ SOLN, 10 mL vial, Rx only, Colonia Care Pharmacy, 51... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, ... Failed dissolution specifications Class II Alvogen, Inc
Jul 24, 2019 Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg... Failed dissolution specifications Class II Alvogen, Inc
Jul 24, 2019 C-METHYLCOBALAMIN 25MG/ML INJECTION PFS, packaged in 0.3 mL, 0.5 mL, 1 mL, an... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ALBUMIN 5% OPHTH SOLUTION, 10 mL droptainer bottles, Rx only, Colonia Care ... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 23, 2019 Mometasone Furoate Cream USP, 0.1%, packaged in a) 15gram tubes (NDC 68462-19... GMP Deviations: Glenmark received complaints stating that mometasone fuorate cream was gritty. Class II Glenmark Pharmaceuticals Inc., USA
Jul 22, 2019 Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise P... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake we... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Tobramycin Irrigation 80 mg/1000 mL Solution, 1000 mL Container, Refrigerate,... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine 30 mg/1 mg/mL Injectable, 2.5 mL Vial, Rx only, Compo... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/0.2 mg/10 mcg/mL Injectable, 2.5 mL... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable, 2.5 mL... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Inj... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable, 2.5 mL V... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded b... Lack of Processing Controls Class II Wise Pharmacy
Jul 22, 2019 Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable, 2.5 mL V... Lack of Processing Controls Class II Wise Pharmacy
Jul 19, 2019 Atorvastatin Calcium Tablet USP 80 mg, a) 90 count (NDC 67877-0514-90) and b)... Failed Dissolution Specifications Class II Ascend Laboratories LLC
Jul 19, 2019 MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as o... Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed micro... Class II Dercher Enterprises, Inc., DBA Gordon Laboratories
Jul 19, 2019 Lisinopril and Hydrochlorothiazide Tablets USP, 20 mg/12.5 mg, 500-count bott... Presence of Foreign Tablets/Capsules: Product complaint received of one Fenofibrate tablet 145mg ... Class II Lupin Pharmaceuticals Inc.
Jul 18, 2019 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter... Lack of Assurance of Sterility: Bags have potential to leak. Class II Baxter Healthcare Corporation
Jul 18, 2019 Keppra (levetiracetam) 1000 mg tablets, 60 tablets per bottle, Rx only, Manu... Failed Dissolution Specifications. Class II Ucb, Inc
Jul 18, 2019 Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) ... Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergono... Class III Amneal Pharmaceuticals, Inc.
Jul 18, 2019 Neomycin Sulfate 3.5 mg/Polymyxin B Sulfate 10,000 units/Dexamethasone 1 mg ... CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufactur... Class II Preferred Pharmaceuticals, Inc
Jul 17, 2019 Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub... Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c... Class III Lupin Pharmaceuticals Inc.
Jul 17, 2019 Lisinopril and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg, 100 tablet bot... Presence of Foreign Substance; Product complaints received related to brownish/blackish stains on... Class II Lupin Pharmaceuticals Inc.
Jul 17, 2019 Timolol-Latanoprost P-F (0.5/0.005%) ophthalmic drops, packaged in 5mL bottle... Subpotent Drug Class II ImprimisRx NJ
Jul 17, 2019 Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 333... Failed Dissolution Specifications Class II Macleods Pharma Usa Inc
Jul 17, 2019 Timolol- Dorzolamide- Latanoprost P-F (0.5/2.0/0.005%) ophthalmic drops, pack... Subpotent Drug Class II ImprimisRx NJ
Jul 16, 2019 Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07)... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: ... Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enume... Class II Bionpharma Inc.
Jul 16, 2019 Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 180 mg, packaged in a) 5-count bottle (NDC 67877-541-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 15, 2019 CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moi... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 15, 2019 CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 15, 2019 DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Jul 15, 2019 LA FRESH travel lite Sunnyside Lotion Wipe silky, non-greasy formula smooth, ... Marketed without an Approved NDA/ANDA: The product may be construed a sunscreen due to labeling o... Class II La Fresh Group, Inc.
Jul 12, 2019 Stone Purger Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 918... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Glauco-Catar Capsules, Distributed by Herbal Doctor Remedies Alhambra, CA 918... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Pain Stopper, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Appetrol Capsules, Distributed by Herbal Doctor Remedies, Alhambra, CA 91801-... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Awake, 500 mg Capsules, 90-count bottles, Distributed by Herbal Doctor Remedi... CGMP Deviations: Products were manufactured outside of the controls required by current Good Manu... Class II Herbal Doctor Remedies
Jul 12, 2019 Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g / Dexamethasone 1 mg/g Ophth... CGMPs Deviations: Insufficient Quality Assurance controls over critical systems in the manufactur... Class II H J Harkins Company Inc dba Pharma Pac

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.