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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

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DateProductReasonClassFirm
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 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 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 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 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 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, 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 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 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 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 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 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 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, 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 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 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 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 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, 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 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, 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 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 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, 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, 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, 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, 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, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (... 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
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, 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, Aging 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, 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, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL O... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Eac... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Aug 26, 2023 Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... Non-Sterility Class I Dr. Berne's Whole Health Products
Aug 22, 2023 Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1... Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity T... Class II Sofie Co dba Sofie
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIU... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, tota... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, 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.