Browse Drug Recalls
21 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 21 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 21 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 26, 2025 | STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Beth... | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | Class II | B BRAUN MEDICAL INC |
| Aug 26, 2025 | 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL... | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | Class II | B BRAUN MEDICAL INC |
| Aug 18, 2025 | Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medica... | Presence of Particulate Matter | Class I | B BRAUN MEDICAL INC |
| Aug 18, 2025 | 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medi... | Presence of Particulate Matter. | Class I | B BRAUN MEDICAL INC |
| Aug 4, 2025 | Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Ste... | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Class II | B BRAUN MEDICAL INC |
| Aug 4, 2025 | 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, ... | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Class II | B BRAUN MEDICAL INC |
| Jun 16, 2025 | 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containe... | Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal proc... | Class II | B BRAUN MEDICAL INC |
| Apr 18, 2020 | Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Dupl... | Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Pol... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Conta... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, C... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No.... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB C... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL ... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 m... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Nov 21, 2013 | Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Containe... | Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products du... | Class I | B. Braun Medical Inc |
| Oct 15, 2013 | Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Deliver... | Presence of Particulate Matter: The 1g Cefepime for Injection USP and Dextrose Injection USP lot... | Class I | B. Braun Medical 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.