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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 2, 2023 | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B.... | Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructi... | Class III | B. Braun Medical Inc. |
| Jul 27, 2023 | Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured fo... | Failed Impurities/Degradation Specifications | Class III | ALEMBIC PHARMACEUTICALS, INC. |
| Jul 18, 2023 | Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured b... | Out of Specification result observed in content uniformity testing | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 18, 2023 | Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, ... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organ... | Class III | Ascend Laboratories, LLC |
| Jul 5, 2023 | Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one ... | Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 27, 2023 | Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufact... | Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term st... | Class III | Lupin Pharmaceuticals Inc. |
| Jun 23, 2023 | PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only... | Failed Stability Specifications | Class III | Vivus, Inc. |
| Jun 13, 2023 | Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Ma... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | AVKARE LLC |
| Jun 12, 2023 | Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | Amring Pharmaceuticals Inc |
| Jun 6, 2023 | GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisit... | Labeling: Label Mix-up | Class III | HF Acquisition Co LLC |
| May 22, 2023 | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Com... | Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride | Class III | New England Life Care, Inc. dba Advanced Compou... |
| May 18, 2023 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by... | Failed Impurities/Degradation Specifications | Class III | Aurolife Pharma, LLC |
| May 8, 2023 | Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramusc... | Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the p... | Class III | Amneal Pharmaceuticals of New York, LLC |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 27, 2023 | Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets... | Labeling: Incorrect or Missing Package Insert | Class III | Teva Pharmaceuticals USA Inc |
| Apr 24, 2023 | Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablet... | Product mixup: one foreign tablet found in product. | Class III | The Harvard Drug Group |
| Apr 20, 2023 | Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per ... | Labeling: Typographical error on the upper left-hand side of the box and individual patch label t... | Class III | Bryant Ranch Prepack, Inc. |
| Apr 13, 2023 | Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / ... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel PH-101 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 50.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 13, 2023 | Avicel PH-102 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Apr 10, 2023 | Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose ... | Subpotent Drug: Out of specification results for low potency was obtained. | Class III | SCA Pharmaceuticals |
| Mar 29, 2023 | Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-d... | Failed Impurities/Degradation Specifications: Above the specification limits yielded for related ... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 29, 2023 | Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multipl... | Sub-potent drug: assay test result below specifications at 9-month timepoint. | Class III | Accord Healthcare, Inc. |
| Mar 27, 2023 | Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect. | Class III | Pine Pharmaceuticals, LLC |
| Mar 27, 2023 | Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 3... | Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A. | Class III | Teva Pharmaceuticals USA Inc |
| Mar 16, 2023 | Epinephrine Professional EMS, Epinephrine Convenience Kit, Epinephrine 1 mg/m... | Labeling; Incorrect NDC number on outer carton of product. | Class III | Focus Health Group Inc |
| Mar 9, 2023 | Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured... | Failed Content Uniformity Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 8, 2023 | MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed ... | Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry... | Class III | Pfizer Inc. |
| Feb 24, 2023 | Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-... | Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed d... | Class III | Zydus Pharmaceuticals (USA) Inc |
| Feb 24, 2023 | Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentratio... | Subpotent Drug | Class III | SCA Pharmaceuticals |
| Feb 21, 2023 | Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 f... | Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Stan... | Class III | Padagis US LLC |
| Feb 17, 2023 | DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. (28 gm), Manufactured for: Akron Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Akron Pharma, Inc. |
| Feb 17, 2023 | Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured... | Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800... | Class III | Sciegen Pharmaceuticals Inc |
| Feb 15, 2023 | Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One... | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Feb 15, 2023 | Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One... | Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydro... | Class III | AVEVA Drug Delivery Systems, Inc. |
| Feb 2, 2023 | Dermoplast FIRST AID ANTIBACTERIAL SPRAY (Benzethonium chloride 0.2% First ai... | Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing. | Class III | Advantice Health, Llc |
| Feb 1, 2023 | BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., Net Content/Gross W... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Feb 1, 2023 | Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Feb 1, 2023 | Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/G... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Feb 1, 2023 | Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/... | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductiv... | Class III | DuPont Nutrition USA, Inc |
| Jan 30, 2023 | Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The ... | Failed Stability Specifications: Out of specification test results for viscosity was identified a... | Class III | Akorn, Inc. |
| Jan 20, 2023 | Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for:... | Subpotent Drug: Low assay result observed during long-term stability testing. | Class III | Lupin Pharmaceuticals Inc. |
| Jan 13, 2023 | FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free ... | Short Fill: Underfilled units. | Class III | OurPharma LLC |
| Jan 5, 2023 | Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for... | Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package inse... | Class III | MACLEODS PHARMA USA, INC |
| Jan 4, 2023 | SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx ... | Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dis... | Class III | Intersect ENT, Inc. |
| Dec 27, 2022 | Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cad... | Subpotent Drug: Out of specification for assay at the 18-month stability timepoint. | Class III | Jubilant Cadista 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.