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 |
|---|---|---|---|---|
| Nov 13, 2023 | Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), pa... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packag... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 8, 2023 | Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, h... | MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide | Class I | SUGARMDS LLC |
| Nov 6, 2023 | VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manu... | Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicilliu... | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 31, 2023 | LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (1... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | Cardinal Health Inc. |
| Oct 31, 2023 | LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bot... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | Cardinal Health Inc. |
| Oct 31, 2023 | LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL)... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | Cardinal Health Inc. |
| Oct 31, 2023 | LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | Cardinal Health Inc. |
| Oct 31, 2023 | LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 F... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | Cardinal Health Inc. |
| Oct 31, 2023 | Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 31, 2023 | LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, ... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | Cardinal Health Inc. |
| Oct 31, 2023 | Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bo... | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 23, 2023 | Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL uni... | Failed Content Uniformity Specifications | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Oct 20, 2023 | Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenz... | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Class I | Botanical Be |
| Oct 20, 2023 | Artri King Reforzado con Origa y Omega 3 tablets, packaged in 100-count bottl... | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Class I | Botanical Be |
| Oct 20, 2023 | Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukam... | Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac. | Class I | Botanical Be |
| Oct 18, 2023 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL S... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 18, 2023 | Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Si... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 18, 2023 | ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 ... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 18, 2023 | Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottle... | Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. | Class I | VistaPharm LLC |
| Oct 16, 2023 | THE ROCK, Male Sexual Performance Enhancement Capsules, 1200 mg, 1 count blis... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with Sildenaf... | Class I | Noah's Wholesale LLC |
| Oct 2, 2023 | 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of U... | Presence of Particulate Matter: identified as glass. | Class I | Pfizer Inc. |
| Oct 2, 2023 | 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Us... | Presence of Particulate Matter: identified as glass. | Class I | Pfizer Inc. |
| Oct 2, 2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJEC... | Presence of Particulate Matter: identified as glass. | Class I | Pfizer Inc. |
| Sep 29, 2023 | ION*Sinus Spray, 1 fl oz/ 30 mL, Manufactured by: ION* Biome Charlottesville, VA | Microbial contamination of Non-Sterile Products | Class I | Biomic Sciences, LLC dba ION Intelligence of Na... |
| Sep 25, 2023 | BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufact... | Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate d... | Class I | Scynexis, Inc. |
| Sep 20, 2023 | Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech In... | Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP... | Class I | KVK-Tech, Inc. |
| Sep 8, 2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. | Class I | Novartis Pharmaceuticals Corp. |
| Sep 8, 2023 | TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride i... | Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis | Class I | Church & Dwight Inc |
| Aug 26, 2023 | Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... | Non-Sterility | Class I | Dr. Berne's Whole Health Products |
| Aug 25, 2023 | Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/D... | Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,... | Class I | Marlex Pharmaceuticals, Inc. |
| Aug 25, 2023 | WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Br... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenaf... | Class I | Hua Da Trading, Inc. dba Wefun Inc. |
| Aug 3, 2023 | Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (In... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenaf... | Class I | APG SEVEN, INC |
| Jun 27, 2023 | Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net con... | Defective container: empty inhaler and leakage observed through the inhaler valve due to partiall... | Class I | Cipla USA, Inc. |
| Jun 23, 2023 | Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 m... | Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specific... | Class I | Lupin Pharmaceuticals Inc. |
| May 31, 2023 | ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on... | Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg we... | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Apr 26, 2023 | NUX Male Enhancement capsule, 1-count blister card, distributed by SX Power C... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, Inc |
| Apr 26, 2023 | DYNAMITE SUPER capsule, 58,000 MG, 1-count blister card, Made in America, UPC... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, Inc |
| Apr 26, 2023 | Pro Power Knight Plus capsule, 2550mg, 1-count blister card, Distributed by B... | Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared s... | Class I | Gadget Island, Inc |
| Apr 20, 2023 | G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric... | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Class I | Novis PR, LLC dba Kramer Novis |
| Mar 27, 2023 | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solutio... | Chemical Contamination: FDA testing found Presence of methanol | Class I | Jarman's Midwest Cleaning Systems, Inc. |
| Mar 27, 2023 | SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STER... | Chemical Contamination: FDA testing found Presence of methanol | Class I | Jarman's Midwest Cleaning Systems, Inc. |
| Mar 13, 2023 | Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manuf... | Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus ce... | Class I | Camber Pharmaceuticals Inc. |
| Feb 24, 2023 | Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83... | Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. | Class I | Global Pharma Healthcare Private Limited |
| Feb 14, 2023 | Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-S... | Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and ace... | Class I | Nanomaterials Discovery Corporation |
| Feb 14, 2023 | Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31... | Non-Sterility | Class I | Pharmedica USA, LLC |
| Feb 13, 2023 | PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-c... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Volt Candy Wholesale Club |
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.