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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 14, 2023 | CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1 Plasmalyte, High Potassium, IV B... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | PHENYLephrine, 40mg/250ml, added to 0.9% sodium chloride, IV Bag, Rx Only, Ce... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | CARDIOPLEGIA SOLUTION, 100 mEq K, Induction 8:1, High Potassium / Low dextros... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | CARDIOPLEGIA SOLUTION 122 mEq K, Modified St. Thomas Formula High Potassium, ... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx... | 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%/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 | CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, tot... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200m... | 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 dextrose 5%/lactated ringers 500 mL, IV Bag, Rx On... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | phenylephrine, 25mg added to 0.9% sodium chloride 250 mL, IV Bag, Rx Only, C... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | CARDIOPLEGIA SOLUTION, 48 mEq K, Induction 4:1 in Ringer's, High Potassium, I... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, tot... | 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) 3%/Dextrose 5% with **low ... | 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 Lactated Ringer's 500 mL, IV Bag, Rx only, Rx only... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, tota... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 14, 2023 | vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/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 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIU... | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jul 13, 2023 | Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil... | Lack of Assurance of Sterility | Class II | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy |
| Jul 11, 2023 | Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For I... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals |
| Jul 11, 2023 | Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, la... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals |
| Jul 11, 2023 | Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals |
| Jul 7, 2023 | Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 7, 2023 | Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 7, 2023 | Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 ... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 7, 2023 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 7, 2023 | Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 m... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 5, 2023 | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B.... | Lack of assurance of sterility: bags have the potential to leak. | Class II | B. Braun Medical Inc. |
| May 25, 2023 | Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx onl... | Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. | Class II | Golden State Medical Supply Inc. |
| May 23, 2023 | Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx onl... | Lack of assurance of sterility: The product was potentially exposed to below-recommended storage ... | Class II | Fresenius Medical Care Holdings, Inc. |
| May 19, 2023 | Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharm... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals Inc |
| May 19, 2023 | Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharm... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals Inc |
| May 19, 2023 | Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd... | Lack of Assurance of Sterility | Class II | Sagent Pharmaceuticals Inc |
| May 15, 2023 | Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only,... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only,... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Crit... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufa... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: ... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Cri... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP, 2 grams per vial, Rx only, Manufactured for: ... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Cefepime for Injection, USP 1 gram per vial, Rx only, Manufactured for: Civic... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Manufactured for: Xe... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Packag... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal C... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP, 1 grams per vial, Rx only, Manufactured for: ... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, ... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Ma... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xe... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manu... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xe... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critica... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
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.