Browse Drug Recalls

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
Jul 24, 2019 C-HYDROXYPROGESTERONE CAPRO 250MG/ML INJECTION, 5 mL vial, Rx only, Colonia C... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Col... 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 C-HYDROXOCOBALAMIN 25 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Coloni... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-HYDROXOCOBALAMIN 5 MG/ML INJECTION SOLUTION, 1 mL syringe, Rx only, Colonia... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
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-PHENOL/COTTONSEED OIL INJ 5%, 5 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 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-PAPAV/PHENTOL/PGE1 18MG/0.6MG/11.8MCG/ML, 10 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-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 30MG/1MG/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-PAPAV/PHENTOL/PGE1 30MG/0.5MG/30MCG/ML, 5 mL vial, Rx only, Colonia Care Ph... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-PAPAV/PHENTOL/PGE1 10MG/1MG/10MCG/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-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 24, 2019 C-MB12 NAC 13MG/48MG/ML INJ SOLN, 0.29 mL in a 0.3 mL syringe, Rx only, Colon... Lack of Assurance of Sterility: product sterility cannot be guaranteed. Class II Colonia Care Pharmacy
Jul 24, 2019 C-ATROPINE SULF OPHTH 0.01%, 5 mL droptainer bottles, Rx only, Colonia Care P... 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 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 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection, 20... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Jul 9, 2019 Milrinone Lactate Injection 200 mcg (0.2 mg)/mL* in 5% Dextrose Injection 40 ... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Pfizer Inc.
Jul 2, 2019 iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops, 10 mL, M... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Homatropine Hydrobromide Ophthalmic Solution, 5%, 5 mL, Rx only, Manu... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Ciprofloxacin HCl Ophthalmic Solution, 0.3%, 5 mL, NDC 59390-217-05 Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Ointment Sensitive Formula, Item#: 247885, 3.5 gram,... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricant Eye Drops (Propylene Glycol 0.6%) Lasting Dry Eye Relief... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Lubricating Gel Drops for Anytime Use, Item#: 563420, 10 mL, Distr... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 ActivEyes Lubricant Eye Ointment Preservative Free, Product Size: 3.5 gram, M... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Dry Eye Relief Lubricant Eye Drops, 0.5 FL OZ (15 mL), Distributed... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Tears Again Sterile Lubricant Eye Drops, Net Wt 30mL (1 fl oz), Manuf... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Natural Ophthalmics Women's Tear Stimulation Dry Eye Drops, 15 mL, NDC 68770-... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Fast Acting Lubricant Eye Drops Preservative Free, Item#: 994882, ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Puralube Ophthalmic Ointment, 3.5 gram, Mfd. for Perrigo, Minneapolis, MN 554... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Extra Strength Lubricant Gel Drops (Carboxymethyl-Cellulose Sodium... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactu... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Fast Acting Lubricant Eye Drops (Polyethylene Glycol 400, 0.4% Pro... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50 Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Natural Ophthalmics Cataract Eye Drops with Cineraria, 15 mL, 25 mL, NDC 687... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Natural Tears Lubricant Eye Drops, Preservative Free Ophthalmic So... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Fre... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic, Rx only, 5 m... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product S... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Maximum Redness Relief Lubricant Redness Reliever Eye Drops, Steri... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 CVS Health Overnight Lubricating Eye Ointment, Sterile, Net wt. 0.125 oz. (3.... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Nano Tears TF Clear Emollient Lubricant Gel Drops Preservative Free, Product ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops, 15 mL, NDC 68770-10... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Accutome Rx Accu-WASH, 4 FL OZ (118 mL), Manufactured for: Accutome Inc 3222 ... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Altaire Diclofenac Sodium Opthalmic Solution, 0.1%, 5 mL, Rx only, Manufactur... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, Inc.
Jul 2, 2019 Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package... Lack of Assurance of Sterility Class II Altaire Pharmaceuticals, 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.