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Browse Drug Recalls

1,122 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,122 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 1,122 FDA drug recalls in 2023.

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DateProductReasonClassFirm
Sep 22, 2023 Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx onl... Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two ... Class III West-Ward Columbus 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 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 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 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 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 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 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 20, 2023 MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile O... Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0%... Class III Imprimis NJOF, LLC
Sep 20, 2023 Betaxolol Tablets, USP 10 mg, Rx Only, 100 count bottles, Mfd by: KVK Tech In... Presence of Foreign Tablets/Capsules: There is a potential presence of oxycodone HCl tablets, USP... Class I KVK-Tech, Inc.
Sep 12, 2023 Eligard (leuprolide acetate) for injectable suspension, 7.5 mg every month, S... Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product. Class III Tolmar, Inc.
Sep 8, 2023 SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals. Class I Novartis Pharmaceuticals Corp.
Sep 8, 2023 TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride i... Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis Class I Church & Dwight Inc
Sep 7, 2023 Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... Subpotent: Out of Specification result observed for low assay Class III SUN PHARMACEUTICAL INDUSTRIES 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 5, 2023 Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalypto... Incorrect/Undeclared Excipients. Class III Vi-Jon, LLC
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

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.