Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

Clear
DateProductReasonClassFirm
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
Jun 2, 2025 KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Sl... Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... Class II Tailstorm Health INC
May 30, 2025 TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml ... Marketed Without an Approved NDA/ANDA Class II Advanced Pharmaceutical Technology, Inc.
May 30, 2025 Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactur... Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsul... Class II Zydus Pharmaceuticals (USA) Inc
May 29, 2025 Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL ... Failed Stability Specifications: Out of specification results for the Color Absorbance test duri... Class II Eugia US LLC
May 28, 2025 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, R... Lack of Assurance of Sterility Class II Apotex Corp.
May 28, 2025 Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Ap... Defective Container: This recall is being initiated due to a leaking unit stored horizontally. Class II Apotex Corp.

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.