Browse Drug Recalls

1,702 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,702 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 1,702 FDA drug recalls, Class III.

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DateProductReasonClassFirm
May 26, 2020 Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: P... Failed Impurities/ Degradation Specifications Class III Aurobindo Pharma USA Inc.
May 19, 2020 Zilretta (triamcinolone acetonide extended-release injectable suspension), 32... Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertent... Class III Flexion Therapeutics, Inc.
May 14, 2020 Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter... Class III InvaGen Pharmaceuticals, Inc.
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 5, 2020 Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, R... Short Fill Class III Exela Pharma Sciences LLC
Apr 24, 2020 Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... Class III The Harvard Drug Group
Apr 24, 2020 Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bott... Discoloration: product contains brown pellets Class III Dr. Reddy's Laboratories, Inc.
Apr 23, 2020 R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride ... Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac Class III QuVa Pharma, Inc.
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Mar 25, 2020 Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per car... Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.... Class III Akorn Inc
Mar 23, 2020 Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceutical... Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule... Class III Mylan Pharmaceuticals Inc.
Mar 9, 2020 Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and e... Failed Content Uniformity Specifications: Out Of Specification test results observed for content ... Class III Lupin Pharmaceuticals Inc.
Mar 4, 2020 PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par... Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre... Class III Par Pharmaceutical Inc.
Feb 27, 2020 Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do... Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... Class III The Harvard Drug Group
Feb 27, 2020 Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos... Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... Class III The Harvard Drug Group
Feb 27, 2020 Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do... Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... Class III The Harvard Drug Group
Feb 27, 2020 Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do... Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... Class III The Harvard Drug Group
Feb 24, 2020 Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous ... Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impuritie... Class III Breckenridge Pharmaceutical, Inc
Feb 21, 2020 Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, D... Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... Class III Akorn, Inc.
Feb 21, 2020 CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distribu... Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... Class III Akorn, Inc.
Feb 21, 2020 Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: A... Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... Class III Akorn, Inc.
Feb 17, 2020 Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count b... Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chlor... Class III Strides Pharma Science Limited
Feb 14, 2020 Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 m... Labeling: Incorrect or Missing Lot and/or Expiration date. Class III AAA Pharmaceutical, Inc.
Feb 12, 2020 TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC ... Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ... Class III Golden State Medical Supply Inc.
Feb 10, 2020 Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablet... Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiratio... Class III Par Pharmaceutical Inc.
Feb 7, 2020 Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose... Failed Impurities/Degradation Specifications: elevated levels of Benzaldehyde impurity was found ... Class III AuroMedics Pharma LLC
Jan 29, 2020 Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufa... Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure... Class III UNICHEM PHARMACEUTICALS USA INC
Jan 28, 2020 Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottl... Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ... Class III Teva Pharmaceuticals USA
Jan 24, 2020 Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, ... Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitaz... Class III Macleods Pharma Usa Inc
Jan 22, 2020 Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bo... Failed Dissolution Specifications: low out of specification results for dissolution testing. Class III Ascend Laboratories LLC
Jan 20, 2020 Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufac... Failed Dissolution Specifications: testing revealed low out of specification result in one lot o... Class III Macleods Pharma Usa Inc
Jan 15, 2020 Magnesium Chloride Injection, MAGNESIUM CHLORIDE 20% INJECTABLE, For IV Use,... Lack of Assurance of Sterility Class III Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jan 14, 2020 methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only... Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to rec... Class III Hikma Pharmaceuticals USA Inc.
Jan 10, 2020 Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.0... CGMP Deviations: Out of specification test result observed during retrospective review of blend u... Class III Lupin Pharmaceuticals Inc.
Jan 7, 2020 Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET W... Microbial contamination of non-sterile product. Class III Sigan Industries Inc.
Dec 26, 2019 Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper ... Chemical contamination; out of specification results obtained for equipment cleaning residue rins... Class III Akorn, Inc.
Dec 20, 2019 PCA Skin Blemish Control Bar, 3.2 oz/90g, Salicylic acid 2% - Acne cleanser, ... Superpotent Drug: Salicylic acid content is above the firm's specification. Class III Island Kinetics, Inc. d.b.a. CoValence Laborato...
Dec 16, 2019 NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 16, 2019 NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 16, 2019 NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 ... Subpotent Drug Class III Pharmedium Services, LLC
Dec 13, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III The Harvard Drug Group
Dec 13, 2019 Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx... Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other i... Class III Lupin Pharmaceuticals Inc.
Dec 10, 2019 Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-co... Failed Dissolution Specifications: High out of specification result observed at stability studies. Class III Lupin Pharmaceuticals Inc.
Dec 2, 2019 Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For... Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution. Class III AuroMedics Pharma LLC
Nov 25, 2019 VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 ... Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the pro... Class III Apothecus Pharmaceutical Corp.
Nov 20, 2019 SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, ... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deod... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net W... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs

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.