Browse Drug Recalls
17,539 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,539 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 17,539 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 22, 2024 | Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Me... | Lack of assurance of sterility: bags have the potential to leak.. | Class II | B. Braun Medical Inc |
| Mar 22, 2024 | fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, I... | Lack of Assurance of Sterility: leaking bags | Class II | IntegraDose Compounding Services LLC |
| Mar 21, 2024 | VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9... | cGMP Diviations | Class II | Apothecus Pharmaceutical Corp. |
| Mar 21, 2024 | Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lu... | Subpotent Drug | Class II | Lupin Pharmaceuticals Inc. |
| Mar 21, 2024 | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as... | Superpotent Drug: Due to overfilling of drug powder | Class I | Amneal Pharmaceuticals of New York, LLC |
| Mar 19, 2024 | SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres L... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| 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 19, 2024 | Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Weiner Boner Honey, 12g packet, 100% Organic Formula. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Samurai-X Honey 6800, UPC 2 56891 27553 3. | 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 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 | 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 | 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 Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL ... | 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 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 | 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 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 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 | 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 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 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 Pink 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 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 |
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.