Browse Drug Recalls
37 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 37 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 37 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 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 |
| Mar 31, 2025 | 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL... | Presence of Particulate Matter | Class II | B. Braun Medical Inc |
| Jul 24, 2024 | 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Brau... | Presence of Particulate Matter | Class I | B. Braun Medical Inc |
| Mar 22, 2024 | Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Me... | Lack of assurance of sterility: bags have the potential to leak.. | Class II | B. Braun Medical Inc |
| Mar 6, 2024 | Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), ... | Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, spec... | Class II | B. Braun Medical Inc |
| Aug 2, 2023 | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B.... | Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructi... | Class III | B. Braun Medical Inc. |
| 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 9, 2023 | Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dext... | Subpotent: Low anti-factor IIa Potency. | Class II | B. Braun Medical Inc |
| Mar 1, 2023 | Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dext... | Subpotent Drug: low Anti-Factor IIa potency. | Class II | B. Braun Medical Inc |
| Feb 10, 2023 | 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B... | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... | Class II | B. Braun Medical Inc. |
| Feb 10, 2023 | 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B.... | Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... | Class II | B. Braun Medical Inc. |
| Nov 25, 2022 | 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC ... | Lack of sterility assurance: Bags have the potential to leak. | Class II | B. Braun Medical, Inc. |
| Apr 13, 2022 | Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex co... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 13, 2022 | Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex c... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| Feb 25, 2022 | 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun... | Lack of sterility assurance: leaking bags | 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 |
| Jun 13, 2019 | Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextr... | Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa pot... | Class II | B. Braun Medical Inc |
| Feb 16, 2018 | 0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PI... | Presence of Particulate Matter: Customer complaint of particulate matter which has been identifie... | Class II | B. Braun Medical Inc |
| Dec 15, 2017 | 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), ... | Presence of Particulate Matter: identified as polyethylene, which is consistent with the material... | Class II | B. Braun Medical Inc |
| Mar 25, 2016 | 5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun... | Non-Sterility: fungal contamination due to leaking containers. | Class I | B. Braun Medical Inc |
| Nov 27, 2013 | 0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Bra... | Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 ... | Class II | 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.