Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 29, 2023 | ION* Sinus Support Nasal Spray, 1 fl oz/30 ml bottles, Manufactured by: ION* ... | Microbial contamination of Non-Sterile Products | Class II | Biomic Sciences, LLC dba ION Intelligence of Na... |
| Sep 29, 2023 | Restore Sinus Spray, Manufactured by: Biomic Sciences, LLC Charlottesville, VA | Microbial contamination of Non-Sterile Products | Class II | Biomic Sciences, LLC dba ION Intelligence of Na... |
| Sep 28, 2023 | Gynazole-1, (Butoconazole Nitrate) Vaginal Cream USP, 2%, Net Wt 5.8 g per pr... | Incorrect Product Formulation: Hydrophilic Colloidal Silica was used to manufacture the product r... | Class II | Padagis US LLC |
| Sep 28, 2023 | Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL... | Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial.... | Class II | Eugia US LLC |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Cen... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syring... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | PHENYLephrine in 0.9 sodium chloride, 400 mcg/10 mL, (40 mcg/mL), 10 mL Syrin... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc.... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAP... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 6... | Failed Dissolution Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Sep 21, 2023 | ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only,... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixtu... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL s... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAP... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admix... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total V... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syrin... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syring... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total V... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 793... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx o... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central ... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 21, 2023 | HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe,... | Lack of assurance of sterility: | Class II | Central Admixture Pharmacy Services Inc |
| Sep 5, 2023 | Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-... | Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. | Class II | BE PHARMACEUTICALS AG |
| Sep 1, 2023 | TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 m... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ ... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 g... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL ... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ ... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
| Sep 1, 2023 | TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (... | Lack of Assurance of Sterility | Class II | AMMAN PHARMACEUTICAL INDUSTRIES |
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.