Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 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 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 | 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 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 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 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 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 | 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 | 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 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 | 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 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 | 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 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 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 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 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 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 |
| 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 | 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 | 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 | Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distribut... | CGMP Deviations | Class II | Amerisource Health Services LLC |
| Jan 25, 2024 | Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent Internat... | CGMP Deviations | Class II | Alpha Aromatics |
| 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 19, 2024 | Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 d... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Omeza Skin Protectant, Skin Protectant Gel 10*2mL Vials | CGMP Deviations | Class II | OMEZA LLC |
| Jan 19, 2024 | Omeza Lidocaine Lavage pain relief oil 10*2mL VIALS | CGMP Deviations | Class II | OMEZA LLC |
| Jan 19, 2024 | Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic,... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 18, 2024 | Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hou... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distr... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 18, 2024 | Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablet... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES 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.