Browse Drug Recalls
1,710 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,710 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 1,710 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 7, 2021 | Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured ... | Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability t... | Class III | Bausch Health Companies, Inc. |
| Dec 23, 2020 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, ... | Presence of Foreign Substance: Particulate matter was found in multiple lots of product. | Class III | Genus Lifesciences Inc. |
| Dec 22, 2020 | NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactur... | Failed Moisture Limits | Class III | Strides Pharma Inc. |
| Dec 22, 2020 | Epinephrine/Lidocaine HCl, Sterile Ophthalmic Solution for Injection, 0.8 mL ... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Edge Pharma, LLC |
| Dec 18, 2020 | Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, R... | Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide i... | Class III | KVK-Tech, Inc. |
| Dec 17, 2020 | Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 m... | Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integra... | Class III | SCA Pharmaceuticals |
| Dec 16, 2020 | Succinylcholine Chloride PF Inj. 200 mg/10 mL, 10 mL single use syringes, Rx ... | Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in... | Class III | US Compounding Inc |
| Nov 25, 2020 | Neostigmine Methylsulfate PF Inj. 5 mg/5 mL, 5 mL Single Use Syringes, Hospit... | Labelling: Missing label. | Class III | US Compounding Inc |
| 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 | 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 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 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 | 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 |
| 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 |
| 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 | 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 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 | 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 | 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 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 | 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. |
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.