Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 23, 2021 | Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, C... | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... | Class II | The Procter & Gamble Company |
| Nov 19, 2021 | AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vi... | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... | Class I | American Screening LLC |
| Nov 19, 2021 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count... | Product Mix-up | Class II | Ascent Pharmaceuticals, Inc. |
| Nov 19, 2021 | Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/... | Subpotent Drug | Class III | Lupin Pharmaceuticals Inc. |
| Nov 17, 2021 | Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aero... | Chemical contamination: Presence of benzene | Class I | Blistex Inc |
| Nov 17, 2021 | Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Aut... | Temperature Abuse; temperature excursion during shipping | Class I | Sandoz Inc |
| Nov 17, 2021 | Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, F... | Lack of Assurance of Sterility | Class II | ASP CARES |
| Nov 17, 2021 | Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, Fo... | Lack of Assurance of Sterility | Class II | ASP CARES |
| Nov 17, 2021 | Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, Fo... | Lack of Assurance of Sterility | Class II | ASP CARES |
| Nov 15, 2021 | Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by... | Failed Impurities/Degradation Specifications | Class III | Aurobindo Pharma USA Inc. |
| Nov 12, 2021 | Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL),... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Inje... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave.,... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Exte... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablet... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL),... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoe... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx o... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets U... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), R... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride ... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg p... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injec... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg p... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injecti... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), R... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), R... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, R... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine H... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 12, 2021 | NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Inj... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Inje... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Nov 12, 2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... | Failed dissolution specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| Nov 9, 2021 | Buprenorphine HCl, Injection, 0.3mg/mL, For Intramuscular or Intravenous Use,... | Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during ... | Class II | PAR Sterile Products LLC |
| Nov 8, 2021 | Clindamycin and Benzoyl Peroxide Gel, 1%/5% 25 g jars, Rx only, Mfg by TOLMAR... | Superpotent Drug | Class II | TOLMAR, Inc. |
| Nov 8, 2021 | Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, ND... | Defective Container: Customer complaints for leaking bottles and dispensing issues. | Class II | Medline Industries Inc |
| Nov 4, 2021 | Flocinolone Acetonide 0.01% Topical Oil, Body Oil, Rx, packaged in 4 oz. bott... | Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Nov 4, 2021 | Flocinolone Acetonide 0.01% Topical Oil, Scalp Oil, Rx, packaged in 4 oz. bot... | Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide. | Class II | Amneal Pharmaceuticals of New York, LLC |
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.