Browse Drug Recalls
2,012 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,012 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 2,012 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 18, 2026 | Lidocaine HCl Injection, USP 2%, 40 mg/2 mL (20 mg/mL), 2 mL per Single-Dose ... | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | Class III | Eugia US LLC |
| May 14, 2026 | Duloxetine DR Capsules, 30 mg, 30 count bottles, Rx, Relabeled by: Enovachem ... | CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-dulox... | Class II | Asclemed USA Inc. |
| May 11, 2026 | Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, War... | Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labe... | Class II | Haleon US Holdings LLC |
| Apr 30, 2026 | Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are ... | Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg ... | Class II | Safecor Health, LLC |
| Apr 24, 2026 | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, ... | Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food ... | Class II | Teva Pharmaceuticals USA, Inc |
| Apr 16, 2026 | Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, Fo... | Labeling: Missing Label | Class III | American Regent, Inc. |
| Apr 14, 2026 | Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufac... | Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is ... | Class III | Premier Dental Products Co |
| Mar 18, 2026 | Magnesium Sulfate in Water for Injection, 4g/100 mL (40mg/mL) IV bag, further... | Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actua... | Class I | Amneal Pharmaceuticals, LLC |
| Mar 17, 2026 | Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*), 30x5 mL S... | Labelling: Illegible label | Class II | Nephron SC, LLC |
| Mar 3, 2026 | Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... | Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... | Class II | Rising Pharma Holding, Inc. |
| Feb 12, 2026 | Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1... | Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 ... | Class III | Slate Run Pharmaceuticals |
| Jan 15, 2026 | methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton cont... | Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blis... | Class II | Greenstone Llc |
| Dec 27, 2025 | TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per b... | Incorrect Product Formulation: product did not contain insulin as listed in the label. | Class II | Central Admixture Pharmacy Services, Inc (CAPS)... |
| Dec 26, 2025 | parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and ex... | Class III | Haleon US Holdings LLC |
| Dec 16, 2025 | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx o... | Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets. | Class II | SpecGx, LLC |
| Nov 26, 2025 | Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, F... | Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle ... | Class III | Winder Laboratories, LLC |
| Nov 7, 2025 | Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dos... | Defective Container - A defect in the side-seal which allows leakage of product. | Class III | Teva Pharmaceuticals USA, Inc |
| Oct 29, 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 50 mL Flexible Container, Highly con... | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... | Class I | Otsuka ICU Medical LLC |
| Oct 29, 2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL Flexible Container, Highly co... | Labeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the produc... | Class I | Otsuka ICU Medical LLC |
| Oct 17, 2025 | Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet f... | Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly state... | Class II | Aero Healthcare |
| Oct 10, 2025 | Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials, Sterile,... | Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. | Class II | Safecor Health, LLC |
| Oct 9, 2025 | FentaNYL Citrate PF, 500mcg/50 mL (10mcg/mL) in NACL, Injection for IV use, 5... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 9, 2025 | Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 9, 2025 | Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syri... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | STAQ Pharma, Inc. |
| Oct 7, 2025 | Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottl... | Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, ... | Class II | Rising Pharma Holding, Inc. |
| Oct 1, 2025 | Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dos... | Presence of Particulate Matter: Particulate matter identified as glass | Class II | Aspiro Pharma Limited |
| Oct 1, 2025 | ZICAM" MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle, Distribu... | Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to ind... | Class II | Church & Dwight Co., Inc. |
| Sep 12, 2025 | Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl P... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Skin MD by Dr Monika Kiripolsky, Body Acne Cleanser (Benzoyl Peroxide 10%), 7... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Micronized BPO Gel Cleanser 10% (Benzoyl Peroxide 10%) Pantea MD , 7 oz (201 ... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | mel rx Skin, NO DRAMA Benzoyl Peroxide 10% Acne Treatment, 7 oz, 201 g Mel Sk... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | Espumil, Lipophilic foam base, 500 ml, 24G15-T02-115604 | Labeling: Not Elsewhere Classified | Class III | Letco Medical LLC |
| Sep 12, 2025 | ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverl... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Sep 12, 2025 | edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) ... | Chemical Contamination: This recall has been initiated due to elevated levels of benzene that was... | Class II | Private Label Skin Care Inc. |
| Aug 27, 2025 | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg, 90-count bottle, RX only, ... | Labeling: Label Mix Up; Bottles of Meloxicam USP, 7.5mg, 90-count tablets (yellow in color), were... | Class I | Unichem Pharmaceuticals USA Inc. |
| Aug 19, 2025 | Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfat... | Presence of Foreign Tablet/Capsule: Two (2) bottles labeled as Dextroamphetamine Saccharate, Amph... | Class II | Lannett Company Inc. |
| Aug 11, 2025 | Lisdexamfetamine Dimesylate Capsules, 40 mg, 100-count bottles, Rx Only, Dist... | Labeling: Label Mix-up. A bottle labeled as Lisdexamphetamine Dimesylate Capsules 40mg, contained... | Class II | Lannett Company Inc. |
| Aug 5, 2025 | Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled ... | Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, cont... | Class II | Cardinal Health Inc. |
| Aug 5, 2025 | Sensodyne PRONAMEL (Potassium nitrate 5%, Sodium fluoride 0.25%) Active SHIEL... | Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/W... | Class III | Haleon US Holdings LLC |
| Aug 4, 2025 | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq/50 mL (1 mEq/mL), R... | Lack of Assurance of Sterility. | Class II | PFIZER INC |
| Aug 4, 2025 | Vial Label: Epinephrine Injection, USP, 1mg/10mL (0.1 mg/mL), Rx only, Distri... | Lack of Assurance of Sterility. | Class II | PFIZER INC |
| Jul 30, 2025 | Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGeni... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | BPC-157/Thymosin Beta-4 for Injection, a) 10/10mg, b) 15/15mg, c) 15mg/15mg, ... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Low Solubility Peptide Reconstitution Solution for Injection, all strengths a... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Xolair (omalizumab injection), 75 mg/0.5 ml, Rx only, Genentech, Inc., South ... | CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requi... | Class II | Cardinal Health Inc. |
| Jul 30, 2025 | B-Complex for Injection, all strengths and presentations, GenoGenix, LLC, 284... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Elite Stack Reconstitution Solution for Injection, all strengths and presenta... | Lack of Assurance of Sterility | Class II | GenoGenix LLC |
| Jul 30, 2025 | Elite Stack MSC Exosome Reconstitution Solution for Injection, all strengths ... | Lack of Assurance of Sterility | Class II | GenoGenix 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.