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.

Clear
DateProductReasonClassFirm
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.