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 |
|---|---|---|---|---|
| Oct 18, 2024 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured f... | Labeling: Label Mix-Up | Class II | AvKARE |
| Sep 11, 2024 | Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bot... | Temperature abuse: Products exposed to improper temperature above drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Sep 11, 2024 | First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients:... | Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes ... | Class II | Zhejiang Jingwei Pharmaceutical Co., Ltd. |
| Aug 20, 2024 | Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g... | LABELING: LABEL MIX-UP. | Class III | Elevate Oral Care |
| Jul 18, 2024 | Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid ... | Label mix-up: Carton incorrectly labeled. | Class III | Granules Consumer Health Inc. |
| Jul 11, 2024 | Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 ... | Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the ... | Class I | Aurobindo Pharma USA Inc |
| Jul 10, 2024 | Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per ... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg ins... | Class I | Endo Pharmaceuticals, Inc. |
| Jul 8, 2024 | Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose b... | Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found ... | Class I | Hikma Pharmaceuticals USA Inc. |
| Jun 26, 2024 | Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets ... | Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on pa... | Class III | Dr. Reddy's Laboratories, Inc. |
| Jun 25, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by:... | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | Class III | GLOBAL WIDGET LLC |
| Jun 25, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed b... | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | Class III | GLOBAL WIDGET LLC |
| Jun 25, 2024 | Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz ... | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | Class III | GLOBAL WIDGET LLC |
| Jun 25, 2024 | Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by... | Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%. | Class III | GLOBAL WIDGET LLC |
| Jun 21, 2024 | Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Package... | Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrec... | Class I | A-S Medication Solutions LLC |
| May 31, 2024 | Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: ... | Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbita... | Class II | RemedyRepack Inc. |
| May 31, 2024 | Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of ho... | Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferr... | Class III | Washington Homeopathic Products, Inc. |
| May 28, 2024 | Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the fo... | Labeling: Label Mix up; product labeled as pure white petroleum jelly actually contains petroleum... | Class II | Consumer Product Partners, LLC |
| May 17, 2024 | Tivicay PD (dolutegravir) 5mg Tablets for Oral Suspension, 60-count bottles, ... | Labeling: Incorrect Lot and/or Expiration Date: The carton has incorrect expiration of 2026-MAY*,... | Class III | GlaxoSmithKline LLC |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Rel... | Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on ... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), ... | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed),... | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixe... | Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 10, 2024 | Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixe... | Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP... | Class III | Bryant Ranch Prepack, Inc. |
| May 7, 2024 | Drug Vial Label: Zilretta¿ (triamcinolone acetonide extended-release injectab... | Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C. | Class II | PACIRA PHARMACEUTICALS INC |
| Apr 30, 2024 | Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged... | Labeling: Wrong Barcode | Class III | Hikma Injectables USA Inc |
| Apr 29, 2024 | Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL,... | Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. | Class I | Hikma Injectables USA Inc |
| Apr 20, 2024 | Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... | Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate | Class I | Revive Rx LLC dba Revive Rx Pharmacy |
| Apr 2, 2024 | Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent... | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... | Class III | X-Gen Pharmaceuticals Inc. |
| Apr 2, 2024 | Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, ... | Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), sect... | Class III | X-Gen Pharmaceuticals Inc. |
| Mar 6, 2024 | Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... | Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec... | Class II | B. Braun Medical Inc |
| Feb 12, 2024 | CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1... | CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was... | Class II | MCKESSON CORPORATION |
| Feb 7, 2024 | Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MF... | cGMP Deviations: Products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 7, 2024 | Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vi... | cGMP Deviations: Products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 7, 2024 | Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Sy... | cGMP Deviations: Products were stored outside the drug label specifications. | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 5, 2024 | Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when rec... | Labeling: Incorrect or Missing Package Insert | Class II | Lupin Pharmaceuticals Inc. |
| Jan 23, 2024 | Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL),... | Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified ... | Class II | Baxter Healthcare Corporation |
| Jan 22, 2024 | Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injectio... | Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyon... | Class II | IntegraDose Compounding Services LLC |
| Jan 17, 2024 | Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Pack... | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouc... | Class II | Henry Schein Inc. and Glove Club HSI Gloves Inc. |
| Jan 16, 2024 | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcoh... | CGMP Deviations: products may not conform to the labeled specifications. | Class II | Den-Mat Holdings, LLC |
| Jan 16, 2024 | Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flav... | CGMP Deviations: products may not conform to the labeled specifications. | Class II | Den-Mat Holdings, LLC |
| Jan 10, 2024 | Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Parabe... | Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while t... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 4, 2024 | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,... | Labeling: Label Mix-up | Class I | Azurity Pharmaceuticals, Inc. |
| Dec 13, 2023 | Selenium Sulfide 2.25% Shampoo, 180mL bottle, Rx Only, Manufactured for: Bi-C... | CGMP Deviations: Stability data does not support expiry date. | Class II | Private Label Partners, Inc. |
| Dec 11, 2023 | NYSTATIN 150 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Class II | Fagron, Inc |
| Dec 11, 2023 | NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Onl... | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Class II | Fagron, Inc |
| Dec 11, 2023 | NYSTATIN 500 MU, Activity (as is): 6482 Units/mg, bulk powder container, Rx O... | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Class II | Fagron, Inc |
| Dec 11, 2023 | NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only... | Labeling: Label Error on Declared Strength: Assay value on the label is incorrect. | Class II | Fagron, Inc |
| Nov 13, 2023 | Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) e... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 10, 2023 | Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25... | Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL ... | Class III | Fagron Compounding Services |
| Nov 9, 2023 | Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C;... | cGMP Deviations | Class II | Family Medical Supply 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.