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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| 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 12, 2023 | ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple... | Mislabeling: preservative free product labeled as preserved. | Class II | Empower Clinic Services LLC dba Empower Pharmacy |
| May 11, 2023 | Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use O... | Sub-potent Drug | Class II | Revive Rx LLC dba Revive Rx Pharmacy |
| May 11, 2023 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 2... | Failed Impurities/Degradation Specifications: Out-of-specification results for total related comp... | Class II | Hikma Pharmaceuticals USA Inc. |
| May 9, 2023 | buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablet... | Failed Dissolution Specifications; during stability testing | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 9, 2023 | HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), ... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
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.