Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 19, 2024 | ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving ... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 12, 2024 | Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 RE... | CGMP Deviations | Class II | Eli Lilly & Company |
| Mar 12, 2024 | Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul,... | The filter included in the carton has an expiration date that has expired prior to the expiration... | Class II | Hikma Pharmaceuticals USA Inc. |
| Mar 7, 2024 | Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic ... | Failed Dissolution Specifications | Class II | Teva Pharmaceuticals USA, 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 |
| Mar 5, 2024 | Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactu... | Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. | Class II | Thea Pharma, Inc. |
| Mar 4, 2024 | Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 4, 2024 | Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenou... | Presence of Particulate Matter. | Class I | Par Sterile Products LLC |
| Mar 4, 2024 | Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... | CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 4, 2024 | Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufact... | Cross Contamination with Other Products:(mycophenolate mofetil). | Class III | Novitium Pharma LLC |
| Mar 1, 2024 | S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging... | Failed Stability Specifications | Class II | Specialty Process Labs LLC |
| Mar 1, 2024 | S.P.Labs, Thyroid, Full Strength, Rx only, For Manufacturing, Processing or R... | Failed Stability Specifications | Class II | Specialty Process Labs LLC |
| Feb 29, 2024 | TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manu... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenou... | Lack of Assurance of Sterility: Firm did not perform process validation. | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Feb 29, 2024 | TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 m... | Lack of Assurance of Sterility: Firm did not perform process validation. | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| Feb 29, 2024 | TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Ma... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufacture... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), ... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manuf... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| Feb 29, 2024 | hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bot... | Lack of Assurance of Sterility | Class II | Optikem International, Inc. |
| 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 | 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 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 | 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 | 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 | 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 | 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 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 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 | 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 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 | 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 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... |
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.