FDA drug recalls
The latest medications recalled in the U.S., straight from the FDA's openFDA Enforcement database — what was recalled, why, and how serious it is. Informational only; for any product you have, follow the FDA's guidance and ask your pharmacist.
Subscribe to the recall feed (RSS) — every new recall as it lands, with the FDA's own stated reason.
Recalls by drug type
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.45% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
0.9% Sodium Chloride Injection
Class IILack of Assurance of Sterility
Fresenius Kabi USA, LLC · Mar 11, 2026
Icosapent Ethyl Capsules
Class IIFailed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
Zydus Pharmaceuticals (USA) Inc · Mar 9, 2026
Semaglutide-Glycine-Cyanocobalamin Injectable
Class IILack of Assurance of Sterility
PAYLESS COMPOUNDERS, LLC · Mar 6, 2026
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*
Class IILack of Assurance of Sterility
Apotex Corp. · Mar 5, 2026
HydroPeptide CLEAR ALLIANCE SERUM
Class IIChemical contamination: Presence of benzene
Owen Biosciences Inc. · Mar 3, 2026
STERILE EYE DROPS SOOTHING TEARS (polyethylene glycol 400 0.4% and propylene gly…
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
Sterile EYE DROPS AC (tetrahydrozoline HCl 0.05%
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
EYE DROPS Advanced Relief
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
SLMD Benzoyl Peroxide Acne Lotion
Class IIChemical contamination: Presence of benzene
Owen Biosciences Inc. · Mar 3, 2026
Sterile EYE DROPS REDNESS LUBRICANT (glycerin 0.25% and naphazoline HCl 0.012%)
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
Dry Eye Relief Eye Drops
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
Sterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%)
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
Ultra Lubricating Eye Drops (polyethylene 400 0.4%
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
SLMD BP Acne Spot Treatment
Class IIChemical contamination: Presence of benzene
Owen Biosciences Inc. · Mar 3, 2026
Artificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%
Class IILack of Assurance of Sterility
K.C. Pharmaceuticals, Inc · Mar 3, 2026
Product label: Temozolomide Capsules
Class IIFailed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Rising Pharma Holding, Inc. · Mar 3, 2026
FHF Farmhouse Fresh
Class IIChemical contamination: Presence of benzene
Owen Biosciences Inc. · Mar 3, 2026
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply
Class INon-Sterility: microbial contamination identified as Paenibacillus phoenicis
Cardinal Health 200, LLC · Mar 2, 2026
Children's Ibuprofen Oral Suspension
Class IIPresence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
STRIDES PHARMA INC · Mar 2, 2026
Semaglutide Inj
Class IILack of Assurance of Sterility
New Life Pharma LLC · Feb 26, 2026
Tirzepatide Inj
Class IILack of Assurance of Sterility
New Life Pharma LLC · Feb 26, 2026
Tirzepatide Inj
Class IILack of Assurance of Sterility
New Life Pharma LLC · Feb 26, 2026
Levothyroxine Sodium Tablets USP 150 mcg
Class IISubpotent Drug
MACLEODS PHARMA USA, INC · Feb 26, 2026
Semaglutide Inj.
Class IILack of Assurance of Sterility
New Life Pharma LLC · Feb 26, 2026
Amnesteem (Isotretinoin) Capsules
Class IIFailed Dissolution Specifications
MYLAN PHARMACEUTICALS INC · Feb 24, 2026
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empt…
Class IIIFailed Tablet/Capsule Specifications
Radnostix · Feb 19, 2026
Nilotinib Capsules
Class IIIFailed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc. · Feb 18, 2026
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Sour…
Class IIStability Data Does Not Support Expiry Date.
HTO Nevada Inc. dba Kirkman · Feb 18, 2026
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz…
Class IIStability Data Does Not Support Expiry Date.
HTO Nevada Inc. dba Kirkman · Feb 18, 2026
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bo…
Class IIStability Data Does Not Support Expiry Date.
HTO Nevada Inc. dba Kirkman · Feb 18, 2026
Nilotinib Capsules
Class IIIFailed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Cipla USA, Inc. · Feb 18, 2026
Midodrine Hydrochloride Tablets
Class IIDefective container; inadequately sealed blister packaging.
The Harvard Drug Group LLC · Feb 17, 2026
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b…
Class IICGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Harbin Jixianglong Biotech Co., Ltd. · Feb 13, 2026
Amantadine HCl
Class IIFailed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
AvKARE · Feb 13, 2026
Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01;…
Class IICGMP Deviations This recall has been initiated due to failing to complete process validation and bacterial endotoxin method validation before distribution
Harbin Jixianglong Biotech Co., Ltd. · Feb 13, 2026
Eptifibatide Injection
Class IIILabeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Slate Run Pharmaceuticals · Feb 12, 2026
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single dose…
Class IILack of Assurance of Sterility: due to the presence of particulate matter in one unit from the lot, which lab tests have identified as wool fiber.
LEO PHARMA INC · Feb 10, 2026
Showing 40 of 1,769 recalls tracked.
Related: which FDA-approved drugs are no longer marketed — our discontinued-drugs report →
What the recall classes mean
- Class I
- Most serious — a reasonable probability that use will cause serious harm or death.
- Class II
- May cause temporary or medically reversible harm; low probability of serious harm.
- Class III
- Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Data source: U.S. FDA openFDA Drug Enforcement Reports. This page reproduces FDA recall data for reference and is not medical advice. Always follow the FDA's and your pharmacist's guidance.