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 |
|---|---|---|---|---|
| May 15, 2023 | Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Cr... | 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 | Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manuf... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Cri... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Piperacillin and Tazobactam for Injection, UPS, 3.375 grams per vial, Rx only... | 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, Mfg. f... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 10 g per Pharmacy Bulk Package, Rx only, Mfg. f... | 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 | Ampicillin for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xel... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Mfd. for Meitheal Phar... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin and Sulbactam for Injection, USP 3 gram per vial, Rx only, Manufac... | 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 | Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Civi... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 2 g per vial, Rx only, Manufactured for: Xellia... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmac... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Cefepime for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Criti... | 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 1g per vial, Rx only, Manufactured for: Xellia ... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP 1 gram per vial, Rx only, Mfg. for: Piramal Cr... | 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 | 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 and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg.... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Man... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critica... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xell... | 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, Mfg.... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| 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 | Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Cr... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for:... | 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, Mfd fo... | 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 | Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, M... | 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, Mfd ... | 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, M... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 2, 2023 | VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe,... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Ap... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe,... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only,... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Ap... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, A... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, A... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, A... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
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.