Browse Drug Recalls
17,616 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,616 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 17,616 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 21, 2023 | Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distri... | cGMP deviations: Batch was released prior to approval. | Class II | Aurobindo Pharma USA Inc. |
| Jul 21, 2023 | Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules pe... | CGMP deviation: product released prior to supplier approval. | Class II | The Ritedose Corporation |
| Jul 20, 2023 | FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL ... | cGMP deviations: due to shipment of rejected units. | Class II | SCA Pharmaceuticals |
| Jul 18, 2023 | Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, ... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organ... | Class III | Ascend Laboratories, LLC |
| Jul 18, 2023 | Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured b... | Out of Specification result observed in content uniformity testing | Class III | SUN PHARMACEUTICAL INDUSTRIES 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 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 | lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 79... | 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 | 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, 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, 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 | succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc.... | 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 | 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, 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 | 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 | 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 | 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, 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, 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, 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 | 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 | PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syri... | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services Inc |
| Jul 17, 2023 | vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, ... | 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 in Dextrose 5%, 0.5 mg/5 mL (0.1 mg/mL), 5 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 | 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 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 | 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 | ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 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 | 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 | 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 | 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 | 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 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 | 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 | ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 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 | 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 | PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syri... | Lack of assurance of sterility: Lack of validation data for sanitization cycles | Class II | Central Admixture Pharmacy Services Inc |
| Jul 14, 2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Vol... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | vancomycin 2 g/500 mL added to 0.9% Sodium Chloride, 4 mg/mL, IV Bag, Rx only... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This... | 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. |
| Jul 14, 2023 | rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged b... | 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) 4%/Dextrose 10%, total vol... | 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.