Browse Drug Recalls
17,551 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,551 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 17,551 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 29, 2024 | TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 22, 2024 | Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, ... | Failed Stability Specification: Water determination was found not complying with specification. | Class II | Eugia US LLC |
| Feb 20, 2024 | Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Comp... | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 20, 2024 | Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial,... | Failed Impurities/Degradation Specifications: Out of specification for organic impurities | Class II | Eugia US LLC |
| Feb 20, 2024 | Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured... | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... | Class III | Contract Pharmaceuticals Limited Canada |
| Feb 20, 2024 | Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured fo... | Defective Container: Out of specification for weight due to a slow leakage at the 12-month stabil... | Class III | Contract Pharmaceuticals Limited Canada |
| Feb 20, 2024 | Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Dis... | Failed Impurities/Degradation Specifications: Out of specification for organic impurities | Class II | Eugia US LLC |
| Feb 20, 2024 | Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL... | Failed Dissolution Specifications | Class II | Eugia US LLC |
| Feb 20, 2024 | Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Sing... | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 20, 2024 | Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile inje... | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 19, 2024 | 7 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic,... | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... | Class II | Seatex LLC |
| Feb 19, 2024 | 7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scen... | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... | Class II | Seatex LLC |
| Feb 19, 2024 | PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antis... | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... | Class II | Seatex LLC |
| Feb 19, 2024 | PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Clean... | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... | Class II | Seatex LLC |
| Feb 19, 2024 | PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Clean... | CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing ... | Class II | Seatex LLC |
| Feb 16, 2024 | Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine H... | Stability testing failures for one or two of the four active pharmaceutical ingredients among the... | Class II | Global Corporation |
| Feb 16, 2024 | Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine ma... | Stability testing failures for one or two of the four active pharmaceutical ingredients among the... | Class II | Global Corporation |
| Feb 15, 2024 | Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial ... | Presence of Particulate Matter | Class I | Eugia US LLC |
| Feb 14, 2024 | Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays,... | CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex | Class II | Golden State Medical Supply Inc. |
| Feb 13, 2024 | Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottl... | Failed Impurities/Degradation Specifications: Out-of-specification test results. | Class II | Amneal Pharmaceuticals of New York, LLC |
| 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 12, 2024 | ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-c... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... | Class I | FA Online Inc |
| Feb 12, 2024 | Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs... | CGMP Deviations: Out of specification for residual solvents. | Class II | Micro Labs Limited |
| Feb 9, 2024 | Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured b... | Failed Stability Specifications: Out of specification for blend uniformity. | Class II | Micro Labs Limited |
| Feb 9, 2024 | Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net ... | CGMP Deviations: potential presence of Burkholderia cepacia complex | Class II | Apotex Corp. |
| Feb 9, 2024 | Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076... | Failed Dissolution Specifications: results slightly under spec at at 9-months. | Class III | Stason Pharmaceuticals, Inc. |
| Feb 9, 2024 | HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 bli... | an out of specification result obtained during routine stability testing for Impurities. There i... | Class II | The Harvard Drug Group LLC dba Major Pharmaceut... |
| 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 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 | 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 6, 2024 | Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distribut... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undecla... | Class I | Today The World |
| Feb 6, 2024 | Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP uni... | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... | Class II | Mallinckrodt Hospital Products Inc. |
| Feb 6, 2024 | SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distrib... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Today The World |
| Feb 6, 2024 | Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Today The World |
| Feb 6, 2024 | Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only... | cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Af... | Class II | Mallinckrodt Hospital Products Inc. |
| Feb 5, 2024 | Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bo... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 5, 2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, D... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Super Chill Products |
| 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. |
| Feb 2, 2024 | Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This pac... | Subpotent Drug: Out of specification for assay | Class II | Bausch Health Companies, Inc. |
| Feb 1, 2024 | Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactur... | CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on ... | Class II | NATCO Pharma Limited |
| Feb 1, 2024 | TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 o... | Chemical Contamination; presence of benzene. | Class I | Insight Pharmaceuticals LLC, a Prestige Consume... |
| Feb 1, 2024 | RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a ... | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. | Class I | Integrity Products |
| Feb 1, 2024 | HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit d... | Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged... | Class III | Amerisource Health Services LLC |
| Feb 1, 2024 | To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing ... | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. | Class I | Integrity Products |
| Jan 30, 2024 | Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Package... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrol... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 30, 2024 | Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Pa... | Lack of Assurance of Sterility | Class II | Brassica Pharma Pvt Ltd |
| Jan 25, 2024 | Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in... | Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. | Class III | Teva Pharmaceuticals USA, Inc |
| Jan 25, 2024 | Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... | CGMP Deviations | Class II | Amerisource Health Services 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.