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
Nov 20, 2020 Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceutic... Subpotency: Out-of-specification stability test result for low potency was obtained. Class III SCA Pharmaceuticals
Nov 20, 2020 Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), p... Labeling: Label mix-up Class III Novocol Pharmaceutical of Canada, Inc.
Nov 17, 2020 DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill... Cross Contamination with Other Products: trace amounts of octreotide found during testing Class III Fresenius Kabi USA, LLC
Nov 11, 2020 Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose ... Superpotent Drug: High out-of-specification assay results were obtained during stability testing. Class III Teva Pharmaceuticals USA
Nov 11, 2020 Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, ... Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5... Class III InvaTech Pharma Solutions, LLC
Nov 5, 2020 Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent... Superpotent and Subpotent; low and high assay results Class III Teligent Pharma, Inc.
Nov 3, 2020 Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx Only,... Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results. Class III Teligent Pharma, Inc.
Oct 26, 2020 Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) bli... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
Oct 23, 2020 Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Dis... Failed impurities/ degradation specifications: Out of specification impurity results were observe... Class III Heritage Pharmaceuticals Inc
Oct 22, 2020 Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL ... Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups. Class III Aurobindo Pharma USA Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 9, 2020 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-m... Class III ANI Pharmaceuticals, Inc.
Oct 6, 2020 Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Sha... DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking. Class III eVenus Pharmaceutical Laboratories
Oct 2, 2020 Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, pac... Out-of-specification organic impurity results obtained during routine stability testing. Class III Mylan Pharmaceuticals Inc.
Sep 28, 2020 Fluocinonide Ointment USP 0.05%, packaged in: a) 15 gm tube, NDC 52565-0040-1... Failed Impurities/Degradation - Out-of-specification results for Fluocinolone Acetonide impurity. Class III Teligent Pharma, Inc.
Sep 25, 2020 NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v... Failed Impurties/Degradation Specifications: out of specification results for an impurity for one... Class III VistaPharm, Inc.
Sep 24, 2020 Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 ... Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine... Class III Leadiant Biosciences, Inc.
Sep 24, 2020 Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Man... Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles. Class III Legacy Pharmaceutical Packaging LLC
Sep 17, 2020 Homeopathic Energy Catalyst, 1 fl oz (30 mL) Distributed by: Deseret Biologic... Labeling: Product Contains Undeclared API; Incorrect formulation Class III Grato Holdings, Inc.
Sep 16, 2020 Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Or... Subpotent Drug Class III Arbor Pharmaceuticals Inc.
Sep 9, 2020 Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg... Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9... Class III PAI Holdings, LLC. dba Pharmaceutical Associate...
Sep 9, 2020 Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces ... Labeling: Incorrect or Missing Package Insert: The package insert included in the finished produc... Class III P & L Developments, LLC
Aug 3, 2020 Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine ... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Aug 3, 2020 Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Jul 31, 2020 Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 F... Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due ... Class III The Mentholatum Company
Jul 24, 2020 Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-9... Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... Class III Golden State Medical Supply Inc.
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 20, 2020 Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) ... Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content ... Class III Taro Pharmaceuticals U.S.A., Inc.
Jul 13, 2020 Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx on... Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly sta... Class III Fresenius Kabi USA, LLC
Jul 6, 2020 Skin Medica Acne Treatment Lotion (Benzoyl Peroxide 2.5%), 2 Oz bottle, Distr... SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. Class III Allergan PLC
Jul 6, 2020 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... Cross contamination with other products - OOS discovered during routine stability testing for hig... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jul 6, 2020 Skin Medica Acne System, Contains: Purifying Foaming Wash (Salicylic Acid 2.0... SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints. Class III Allergan PLC
Jun 23, 2020 Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only,... Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... Class III VistaPharm, Inc.
Jun 23, 2020 Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bott... cGMP deviations: one lot of the product was distributed to US Markets despite being rejected duri... Class III Biogen MA Inc.
Jun 23, 2020 Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl... Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... Class III VistaPharm, Inc.
Jun 17, 2020 Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, F... TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerat... Class III HF Acquisition Co. LLC
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
Jun 5, 2020 Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx onl... Discoloration: Out of Specification (OOS) result for APHA Color Test. Class III Akorn, Inc.
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufact... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactu... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
Jun 4, 2020 Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufact... Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... Class III SOMERSET THERAPEUTICS LLC
May 28, 2020 Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-... Presence of Foreign Substance consistent with granules from desiccant packs used during storage Class III AVKARE Inc.
May 27, 2020 Duavee (conjugated estrogens/bazedoxifene) tablets 0.45/20 mg, packaged in 2 ... Failed Dissolution Specifications Class III Pfizer Inc.
May 26, 2020 Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container, Manufactured b... Presence of Foreign Substance visually consistent with the silica granules present in the desicca... Class III Jubilant Cadista Pharmaceuticals, Inc.
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 26, 2020 Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: P... Failed Impurities/ Degradation Specifications Class III Aurobindo Pharma USA 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.