Browse Drug Recalls

268 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 268 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 268 FDA drug recalls in 2026.

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DateProductReasonClassFirm
Mar 11, 2026 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL f... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 m... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL f... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL i... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 ... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 1... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL),... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 11, 2026 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 ... Lack of Assurance of Sterility Class II Fresenius Kabi USA, LLC
Mar 9, 2026 Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactu... Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidiz... Class II Zydus Pharmaceuticals (USA) Inc
Mar 6, 2026 Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL ... Lack of Assurance of Sterility Class II PAYLESS COMPOUNDERS, LLC
Mar 5, 2026 Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx... Lack of Assurance of Sterility Class II Apotex Corp.
Mar 3, 2026 HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE, a)1 FL OZ/30ml; b) ... Chemical contamination: Presence of benzene Class II Owen Biosciences Inc.
Mar 3, 2026 SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 ... Chemical contamination: Presence of benzene Class II Owen Biosciences Inc.
Mar 3, 2026 SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide, 0.5 fl. oz - 15 mL bottles... Chemical contamination: Presence of benzene Class II Owen Biosciences Inc.
Mar 3, 2026 FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION, 2.5% BENZOYL PEROXIDE A... Chemical contamination: Presence of benzene Class II Owen Biosciences Inc.
Mar 3, 2026 STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene ... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%, zinc sulfate 0.25%), 0.5 fl... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 EYE DROPS Advanced Relief, (dextran 70 0.1%, polyethylene glycol 400 1% and t... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Dry Eye Relief Eye Drops, (glycerin 0.2%, hypromellose 0.2% and polyethylene ... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (1... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Ultra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), S... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidon... Lack of Assurance of Sterility Class II K.C. Pharmaceuticals, Inc
Mar 3, 2026 Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx ... Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-... Class II Rising Pharma Holding, Inc.
Mar 2, 2026 Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) b... Presence of foreign substance: the firm received complaints for a gel-like mass and black particl... Class II STRIDES PHARMA INC
Feb 26, 2026 Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manuf... Subpotent Drug Class II MACLEODS PHARMA USA, INC
Feb 26, 2026 Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... Lack of Assurance of Sterility Class II New Life Pharma LLC
Feb 26, 2026 Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Vall... Lack of Assurance of Sterility Class II New Life Pharma LLC
Feb 26, 2026 Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W ... Lack of Assurance of Sterility Class II New Life Pharma LLC
Feb 26, 2026 Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W... Lack of Assurance of Sterility Class II New Life Pharma LLC
Feb 24, 2026 Isotretinoin Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs... Failed Dissolution Specifications Class II MYLAN PHARMACEUTICALS INC
Feb 19, 2026 Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 e... Failed Tablet/Capsule Specifications Class III Radnostix
Feb 18, 2026 Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufac... Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... Class III Cipla USA, Inc.
Feb 18, 2026 MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal S... Stability Data Does Not Support Expiry Date. Class II HTO Nevada Inc. dba Kirkman
Feb 18, 2026 MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1... Stability Data Does Not Support Expiry Date. Class II HTO Nevada Inc. dba Kirkman
Feb 18, 2026 FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz... Stability Data Does Not Support Expiry Date. Class II HTO Nevada Inc. dba Kirkman
Feb 18, 2026 Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufac... Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condit... Class III Cipla USA, Inc.
Feb 17, 2026 Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs)... Defective container; inadequately sealed blister packaging. Class II The Harvard Drug Group LLC
Feb 13, 2026 Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01... CGMP Deviations This recall has been initiated due to failing to complete process validation and ... Class II Harbin Jixianglong Biotech Co., Ltd.
Feb 13, 2026 Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Onl... Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification ... Class II AvKARE
Feb 13, 2026 Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-0... CGMP Deviations This recall has been initiated due to failing to complete process validation and ... Class II Harbin Jixianglong Biotech Co., Ltd.
Feb 12, 2026 Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1... Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 ... Class III Slate Run Pharmaceuticals
Feb 10, 2026 Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single d... Lack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lo... Class II LEO PHARMA INC
Feb 9, 2026 Cetrorelix Acetate for Injection (Kit), 0.25 mg per vial, Single-Dose Kit, Rx... Defective Delivery System: Missing or duplicated needles within the injection kit Class II Meitheal Pharmaceuticals, Inc
Feb 5, 2026 acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injecti... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Inject... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride In... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC
Feb 5, 2026 thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection,... Lack of Assurance of Sterility Class II Fresenius Kabi Compounding, LLC

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.