Browse Drug Recalls
515 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 515 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 515 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 14, 2025 | Testosterone / Triamcinolone Acetonide 25MG/5MCG, 1 PELLET (STERILE) FOR SUBC... | CGMP Deviations: Potential presence of metal particulate matter | Class II | FARMAKEIO OUTSOURCING LLC |
| Oct 10, 2025 | R.E.C.K. (Ropivacaine HCl, EPINEPHrine, CloNIDine HCl, and Ketorolac Trometha... | Presence of Particulate Matter | Class II | QuVa Pharma, Inc. |
| Oct 1, 2025 | Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dos... | Presence of Particulate Matter: Particulate matter identified as glass | Class II | Aspiro Pharma Limited |
| 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 |
| Jul 10, 2025 | Bicillin L-A (penicillin G benzathine injectable suspension), 2,400,000 units... | CGMP Deviations; particulates identified during visual inspection | Class II | Pfizer Inc. |
| Jul 10, 2025 | Bicillin L-A (penicllin G benzathine injectable suspension), 1,200,000 units ... | CGMP Deviations; particulates identified during visual inspection | Class II | Pfizer Inc. |
| Apr 28, 2025 | TESTOSTERONE PELLET 200 mg (with Cholesterol </=2%), 1 Pellet for Subcutaneou... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 28, 2025 | TESTOSTERONE PELLET 200 mg BLUNT (with Cholesterol </=2%), 1 Pellet for Subcu... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 28, 2025 | TESTOSTERONE PELLET 200 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneou... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 28, 2025 | TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Co... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 28, 2025 | TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneou... | Presence of Particulate Matter: Glass particles were found in pellet vials. | Class II | BSO LLC |
| Apr 17, 2025 | Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), M... | Presence of Particulate Matter | Class I | Amneal Pharmaceuticals, LLC |
| 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 |
| Feb 20, 2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx O... | Presence of Particulate Matter | Class I | Central Admixture Pharmacy Services, Inc. |
| Jan 21, 2025 | Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Phar... | Presence of Particulate Matter. | Class I | Provepharm Inc. |
| Dec 27, 2024 | Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vi... | Presence of Particulate Matter: A market complaint was received of a glass piece in the vial. | Class II | Eugia US LLC |
| Nov 11, 2024 | Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... | Presence of Particulate Matter: Potential for glass delamination from the vials. | Class II | American Regent, Inc. |
| Nov 11, 2024 | Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/... | Presence of Particulate Matter: Potential for glass delamination from the vials. | Class II | American Regent, Inc. |
| Nov 11, 2024 | Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/m... | Presence of Particulate Matter: Potential for glass delamination from the vials. | Class II | American Regent, Inc. |
| Sep 30, 2024 | Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, ... | Presence of Particulate Matter: Presence of glass particulates. | Class I | Staska Pharmaceuticals, Inc. |
| Sep 19, 2024 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... | Presence of Particulate Matter: Presence of glass particle. | Class I | Gilead Sciences, Inc. |
| Jul 26, 2024 | Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose ... | Presence of Particulate Matter: Complaint received of a glass particle in the vial. | Class II | Eugia US LLC |
| 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 |
| Jun 27, 2024 | Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only,... | Presence of particulate matter: glass | Class II | Zydus Pharmaceuticals (USA) Inc |
| Jun 26, 2024 | Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystallin... | CGMP Deviations and Presence of Particulate Matter: Glass | Class II | Medisca Inc. |
| May 28, 2024 | Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose ... | Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. | Class I | Sagent Pharmaceuticals |
| May 28, 2024 | Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Do... | Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. | Class I | Sagent Pharmaceuticals |
| Apr 25, 2024 | MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 m... | Presence of Particulate Matter: Potential for black particulates in the drug product. | Class II | Sagent Pharmaceuticals |
| Apr 22, 2024 | Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle... | Failed Release Testing: Out of specification for particulate matter test. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 4, 2024 | Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenou... | Presence of Particulate Matter. | Class I | Par Sterile Products LLC |
| Feb 20, 2024 | Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile inje... | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 20, 2024 | Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Sing... | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 20, 2024 | Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Comp... | Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delaminat... | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 15, 2024 | Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial ... | Presence of Particulate Matter | Class I | Eugia US LLC |
| Jan 19, 2024 | Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic,... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 d... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 dro... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Jan 19, 2024 | CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160... | CGMP Deviations: Potential Glass and Silicone particulates in product | Class II | Bestco LLC |
| Dec 21, 2023 | Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABB... | Presence of Particulate Matter; identified as glass | Class I | Pfizer Inc. |
| Dec 21, 2023 | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, ... | Presence of Particulate Matter; identified as glass | Class I | Pfizer Inc. |
| Dec 21, 2023 | Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop ... | Presence of particulate matter: glass | Class I | PFIZER |
| Dec 21, 2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJE... | Presence of Particulate Matter; identified as glass | Class I | Pfizer Inc. |
| Nov 22, 2023 | B-Complex, Thiamine HCI / Riboflavin / Niacinamide / Dexpanthenol / Pyridoxin... | Presence of Particulate Matter. | Class II | AnazaoHealth Corporation |
| Nov 22, 2023 | Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection Solution, 30mL Amber... | Presence of Particulate Matter. | Class II | AnazaoHealth Corporation |
| Oct 18, 2023 | Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Si... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 18, 2023 | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL S... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 18, 2023 | ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 ... | Presence of Particulate Matter: Silicone | Class I | Exela Pharma Sciences LLC |
| Oct 2, 2023 | 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Us... | Presence of Particulate Matter: identified as glass. | Class I | Pfizer 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.