Browse Drug Recalls
1,723 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,723 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 1,723 FDA drug recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 16, 2026 | UDENYCA, pegfilgrastim-cbqv injection, 6 mg/0.6mL Single Dose Prefilled Syrin... | Temperature Abuse. 116 cartons with specific serial numbers of Lot 2199821, were stored incorrect... | Class I | McKesson |
| Dec 22, 2025 | Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. ... | CGMP Deviations: product found to contain lead. | Class I | HANDELNINE GLOBAL LLC |
| Dec 15, 2025 | MR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7 | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafi... | Class I | StuffbyNainax |
| Dec 12, 2025 | ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura... | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mo... | Class I | Medinatura New Mexico, inc. |
| Dec 12, 2025 | ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, ... | Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mo... | Class I | Medinatura New Mexico, inc. |
| Nov 6, 2025 | Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only... | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. | Class I | Fresenius Kabi USA, LLC |
| 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 20, 2025 | SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Wo... | Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam. | Class I | ANTHONY TRINH, 123Herbals LLC |
| Oct 8, 2025 | Mojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Dist... | Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsul... | Class I | Mohamed Hagar |
| Sep 16, 2025 | Oxytocin 30 Units/500 mL in 0.9% Sodium Chloride for intravenous use, Rx only... | Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. | Class I | IntegraDose Compounding Services LLC |
| Aug 28, 2025 | Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count... | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain tadalafil | Class I | Green Lumber Holdings, LLC |
| 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 18, 2025 | Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medica... | Presence of Particulate Matter | Class I | B BRAUN MEDICAL INC |
| Aug 18, 2025 | 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medi... | Presence of Particulate Matter. | Class I | B BRAUN MEDICAL INC |
| Jul 30, 2025 | NAD+ (Nicotinamide adenine dinucleotide) for Injection, a) 100 mg/mL b) 200 m... | Microbial Contamination of Sterile Products: elevated endotoxin levels | Class I | GenoGenix LLC |
| Jul 17, 2025 | KleenFoam, Antimicrobial Foam Soap with Aloe Vera, (Chloroxylenol 0.5%) 34 FL... | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... | Class I | DermaRite Industries, LLC |
| Jul 17, 2025 | DermaKleen, Health Care Antiseptic Lotion Soap with Vitamin E (Chloroxylenol ... | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... | Class I | DermaRite Industries, LLC |
| Jul 17, 2025 | DermaSarra, External Analgesic, (Camphor 0.5%) 222 mL (7.5 fl. oz.) per bott... | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... | Class I | DermaRite Industries, LLC |
| Jul 17, 2025 | PeriGiene, Health Care Antiseptic, (Chloroxylenol 0.5%) 222 mL (7.5 fl. oz.) ... | Microbial Contamination of Non-Sterile Drug Product: The products were found to be contaminated w... | Class I | DermaRite Industries, LLC |
| Jun 27, 2025 | Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 milli... | Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labele... | Class I | Sandoz Inc |
| Jun 27, 2025 | Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or ... | Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vial... | Class I | Sandoz Inc |
| Jun 6, 2025 | ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church ... | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Class I | Church & Dwight Inc |
| Jun 6, 2025 | ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Dist... | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Class I | Church & Dwight Inc |
| Jun 6, 2025 | Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET... | Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. | Class I | Church & Dwight Inc |
| Jun 2, 2025 | Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100... | Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial... | Class I | Amneal Pharmaceuticals, LLC |
| May 21, 2025 | UMOVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: ERE... | Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclar... | Class I | Umary-USA.com |
| May 21, 2025 | UNAVY ACIDO HIALURONICO, Conenido: 30 capletas de 850mg, distribuido por: ERE... | Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclar... | Class I | Umary-USA.com |
| May 6, 2025 | ENDURANCE BOOST WITH HORNY GOAT WEED, 500mg, 20 capsules per carton, VEPEMVA... | Marketed without approved NDA/ANDA: The product has been found to be tainted with Sildenafil and... | Class I | EnShiShiXiangNiShangMaoYouXianGongSi |
| Apr 17, 2025 | Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), M... | Presence of Particulate Matter | Class I | Amneal Pharmaceuticals, LLC |
| Apr 14, 2025 | Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distr... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| Apr 14, 2025 | MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distr... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| Apr 14, 2025 | Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: He... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| Apr 14, 2025 | ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Dist... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| Apr 14, 2025 | ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health... | Marketed without an Approved NDA/ANDA: Laboratory analysis found the product to be tainted with u... | Class I | SAINI TRADE INC |
| Mar 13, 2025 | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), ... | LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium ... | Class I | Dr. Reddy's Laboratories, Inc. |
| Feb 20, 2025 | Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Ca... | Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and... | Class I | One Source Nutrition, Inc, |
| Feb 20, 2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx O... | Presence of Particulate Matter | Class I | Central Admixture Pharmacy Services, Inc. |
| Feb 14, 2025 | BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and... | Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding. | Class I | CareFusion 213, LLC |
| Feb 13, 2025 | POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case,... | Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain ... | Class I | ICU Medical, Inc. |
| Feb 13, 2025 | POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container... | Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may... | Class I | ICU Medical, Inc. |
| Jan 31, 2025 | Fentanyl Transdermal System CII, 25mcg/h, packaged in a pouch, further packag... | Defective delivery system - patches could be multi-stacked, adhered one on top of the other, in a... | Class I | Alvogen, Inc |
| Jan 28, 2025 | SinuCleanse Premixed SALINE PACKETS (sodium bicarbonate USP 700 mg and sodium... | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Class I | Ascent Consumer Products Inc. |
| Jan 28, 2025 | SinuCleanse Soft Tip NETI POT Nasal Wash System (sodium bicarbonate USP 700 m... | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Class I | Ascent Consumer Products Inc. |
| Jan 28, 2025 | SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System (sodium bicarbonate USP... | Microbial Contamination of Non-Sterile Products: Bacterial contamination with Staphylococcus aureus | Class I | Ascent Consumer Products Inc. |
| Jan 21, 2025 | Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Phar... | Presence of Particulate Matter. | Class I | Provepharm Inc. |
| Dec 23, 2024 | Astagraf XL (tacrolimus extended-release capsules) 0.5 mg, 30-count bottles, ... | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Class I | Astellas Pharma US Inc. |
| Dec 23, 2024 | Prograf (tacrolimus) capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Produc... | Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules | Class I | Astellas Pharma US Inc. |
| Dec 20, 2024 | Adrenalin Chloride Solution (Epinephrine Nasal Solution, USP), 30mg/30mL (1mg... | Labeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved dr... | Class I | ENDO USA, Inc. |
| Dec 18, 2024 | Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufa... | Non-Sterility | Class I | Alcon Research 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.