Browse Drug Recalls
14,136 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,136 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 14,136 FDA drug recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 18, 2025 | Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 un... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj ... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 15, 2025 | Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only,... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jul 11, 2025 | Sucralfate Tablets, USP 1 gram, packaged in a) 100-count bottles NDC 29033-00... | CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it canno... | Class II | Nostrum Laboratories, Inc. |
| Jul 10, 2025 | Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| 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 | Beauty & Skincare Power Stick original nourishing invisible protection roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| 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. |
| Jul 10, 2025 | Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder ... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 9, 2025 | Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy | Subpotent Drug | Class II | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only,... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| Jul 9, 2025 | Cinacalcet Tablets 90 mg, 30-count bottles, Rx only, Manufactured by: Strides... | Failed Dissolution Specifications. | Class II | Strides Pharma, Inc. |
| Jul 9, 2025 | Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy | Subpotent Drug | Class II | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton,... | Sub-Potent Drug: Subpotent assay results during stability testing. | Class II | Imprimis NJOF, LLC |
| Jul 9, 2025 | Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only... | CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended ... | Class II | Ascend Laboratories, LLC |
| Jul 9, 2025 | Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy | Subpotent Drug | Class II | Boothwyn Pharmacy LLC |
| Jul 7, 2025 | H-E-B, inControl, Sterile* Alcohol Pads, CONT. 100 PADS, Packaged in China wi... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | RITE AID PHARMACY, first aid alcohol prep pads, DISTRIBUTED BY: RITE AID. 200... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | Medline Alcohol Prep Pads, 70% Isopropyl Alcohol, 100 Sterile 2-Ply Pads, Sin... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | ReliOn, Sterile Alcohol Swabs, Skin Cleanser, 200 Swabs, Distributed by, Walm... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | CURAD Alcohol Prep Pads, Sterile, Medium, 2-Ply, Contents: 5 boxes per Carton... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 7, 2025 | Good Neighbor Pharmacy, Alcohol Prep Pads, Distributed By AmeriSource Bergen,... | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jul 5, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... | Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. | Class II | FDC Limited |
| Jul 2, 2025 | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle,... | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 i... | Class II | Lupin Pharmaceuticals Inc. |
| Jul 1, 2025 | PERIPHERAL PARENTERAL NUTRITION, Compounded Sterile Preparation, Refrigerated... | Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identifi... | Class II | Central Admixture Pharmacy Services, Inc (CAPS)... |
| Jun 30, 2025 | Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, ... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jun 30, 2025 | Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, M... | Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250m... | Class II | Dr. Reddy's Laboratories, Inc. |
| Jun 30, 2025 | Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carto... | Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule. | Class II | Cipla USA, Inc. |
| Jun 27, 2025 | clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelica... | Failed Impurities/Degradation Specifications: an out of specification result observed in degradat... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 24, 2025 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100... | Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the ... | Class II | Granules Pharmaceuticals Inc. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx On... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx O... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx ... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx ... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Onl... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx O... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles... | Product Mix Up: This product is being recalled because of a complaint received that a sealed bott... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 19, 2025 | Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packag... | Defective container; blister packaging inadequately sealed. | Class II | The Harvard Drug Group LLC |
| Jun 19, 2025 | Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons,... | Defective container; blister packaging inadequately sealed. | Class II | The Harvard Drug Group LLC |
| 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 |
| Jun 16, 2025 | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only,... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 10, 2025 | KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusi... | Subpotent Drug | Class II | IMMUNOCORE, LLC |
| Jun 2, 2025 | LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infil... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| Jun 2, 2025 | LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| Jun 2, 2025 | BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| Jun 2, 2025 | KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow I... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| Jun 2, 2025 | LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRIN... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health 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.