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
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
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
MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal…
Class IIStability Data Does Not Support Expiry Date.
HTO Nevada Inc. dba Kirkman · Feb 18, 2026
MAXIMUM, ZONE 2, 4% Lidocaine Cream, 4% and Epinephrine 0.01%), 1 oz bottles…
Class IIStability Data Does Not Support Expiry Date.
HTO Nevada Inc. dba Kirkman · Feb 18, 2026
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine 0.01%), 4oz…
Class IIStability Data Does Not Support Expiry Date.
HTO Nevada Inc. dba Kirkman · 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…
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
Adbry, (tralokinumab-ldrm) injection, 300 mg/2mL, Packaged as a) 1 x Single…
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
Cetrorelix Acetate for Injection (Kit)
Class IIDefective Delivery System: Missing or duplicated needles within the injection kit
Meitheal Pharmaceuticals, Inc · Feb 9, 2026
acyclovir sodium
Class IILack of Assurance of Sterility
Fresenius Kabi Compounding, LLC · Feb 5, 2026
vancomycin HCl
Class IILack of Assurance of Sterility
Fresenius Kabi Compounding, LLC · Feb 5, 2026
vancomycin HCl
Class IILack of Assurance of Sterility
Fresenius Kabi Compounding, LLC · Feb 5, 2026
ketamine HCl
Class IILack of Assurance of Sterility
Fresenius Kabi Compounding, LLC · Feb 5, 2026
thiamine HCl
Class IILack of Assurance of Sterility
Fresenius Kabi Compounding, LLC · Feb 5, 2026
Dexamethasone Sodium Phosphate Injection
Class IIFailed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
SOMERSET THERAPEUTICS LLC · Feb 4, 2026
Pro Numb Tattoo Numbing Spray
Class IIcGMP deviations
Pro Numb Tattoo Numbing Spray LLC · Feb 2, 2026
Pro Numb Tattoo Numbing Spray
Class IIcGMP deviations
Pro Numb Tattoo Numbing Spray LLC · Feb 2, 2026
Metoprolol Succinate Extended-Release Tablets
Class IIFailed Dissolution Specifications
Teva Pharmaceuticals USA, Inc · Jan 29, 2026
Metoprolol Succinate Extended-Release Tablets
Class IIFailed Dissolution Specifications
Teva Pharmaceuticals USA, Inc · Jan 29, 2026
Metoprolol Succinate Extended-Release Tablets
Class IIFailed Dissolution Specifications
Teva Pharmaceuticals USA, Inc · Jan 29, 2026
Metoprolol Succinate Extended-Release Tablets
Class IIFailed Dissolution Specifications
Teva Pharmaceuticals USA, Inc · Jan 29, 2026
Diclofenac Sodium
Class IIFailed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] result in viscosity for Diclofenac Sodium Gel, 3%.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 27, 2026
ESTRADIOL, 6 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln…
Class IIPresence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Testosterone 75mg
Class IIPresence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Testosterone 100mg Anastrozole 4mg
Class IIPresence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln…
Class IIPresence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Sodium Iodide (I-131) Solution
Class IIPresence of Particulate Matter: Due to production issues
Radnostix · Jan 26, 2026
Testosterone 87.5mg
Class IIPresence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
ESTRADIOL, 18 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln…
Class IIPresence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Testosterone
Class IIPresence of Foreign substance - potential presence of metal particulate matter
F.H. INVESTMENTS, Inc. (dba Asteria Health) · Jan 26, 2026
Showing 40 of 1,576 Class II recalls (1,895 tracked in total).
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.