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Browse Drug Recalls

329 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 329 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 329 FDA drug recalls.

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DateProductReasonClassFirm
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3% / Dextrose 10%, Total V... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, ... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, Total V... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag,... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with HEP... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Ba... 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 dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Cen... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, Central Admixt... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Central Admixture... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx o... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total V... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Central Admixture... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe,... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Vo... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syring... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, R... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL sy... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, R... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total V... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx onl... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixtur... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixt... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Ce... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, R... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syring... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, to... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx o... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium,... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCI... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixtu... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Cent... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CAL... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental ... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FO... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. Class II Central Admixture Pharmacy Services, Inc.
Jul 14, 2023 TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextro... Lack of assurance of sterility. Validation data for decontamination cycles is lacking. 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.