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
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS…
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Carbonate 750 mg, 96 chewable Tablets…
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS…
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
HALEON CALCIUM CARBONATE TUMS ANTACID
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Alyacen 7/7/7
Class IIFailed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
Glenmark Pharmaceuticals Inc., USA · May 27, 2026
Aripiprazole Tablets USP
Class IIProduct Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as Aripiprazole Tablets USP 30 mg.
Ajanta Pharma USA Inc · May 27, 2026
Niacin Extended-release Tablets
Class IIFailed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolution at the 24-hour timepoint.
Lannett Company Inc. · May 27, 2026
Xyvona (levorphanol tartrate tablets)
Class IILabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
SUN PHARMACEUTICAL INDUSTRIES INC · May 22, 2026
Xyvona (levorphanol tartrate tablets)
Class IILabeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona
SUN PHARMACEUTICAL INDUSTRIES INC · May 22, 2026
Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters…
Class IIMicrobial contamination of sterile products
Zep Inc · May 22, 2026
Pearson Quality Topical Anesthetic Gel (20% Benzocaine)
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
safco SensiCaine-Ultra (20% Benzocaine)
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
Dental City TOPICAL ANESTHETIC GEL
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
Burkhart topical anesthetic gel
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
Quala Dental Products
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry…
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
DHP Topical Anesthetic Gel
Class IIDefective container:may contain bottles with incomplete seals
Keystone Industries · May 21, 2026
Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9)
Class IIcGMP deviations
Shimoga Chemicals · May 19, 2026
PReye Vitamin See Antioxidant Preservative Free Eye Drops
Class IILack of Assurance of Sterility
PReye LLC · May 18, 2026
Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride
Class IISubpotent Drug
IntegraDose Compounding Services LLC · May 18, 2026
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL…
Class IIIFailed Stability Specifications
AbbVie Inc. · May 18, 2026
Lidocaine HCl Injection
Class IIILabeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Eugia US LLC · May 18, 2026
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams…
Class IIDoes Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
PAI Holdings LLC · May 15, 2026
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 25 Grams…
Class IIDoes Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
PAI Holdings LLC · May 15, 2026
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 25 Grams…
Class IIDoes Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
PAI Holdings LLC · May 15, 2026
VistaPharm, KERR INSTA-CHAR IN AN AQUEOUS BASE WITH CHERRY FLAVOR, 50 Grams…
Class IIDoes Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
PAI Holdings LLC · May 15, 2026
Duloxetine DR Capsules
Class IICGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit.
Asclemed USA Inc. · May 14, 2026
Epinephrine Injection
Class IIIFailed Impurities/Degradations Specifications
Fresenius Kabi USA, LLC · May 14, 2026
Nicotine Transdermal System Patch
Class IIIFailed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
AVEVA Drug Delivery Systems, Inc. · May 14, 2026
Estradiol Gel
Class IIDefective Container; packets were found to be either empty or partially full.
ANI Pharmaceuticals, Inc. · May 12, 2026
DOXOrubin Hydrochloride Liposome injection
Class IPresence of Particulate matter: Particulate matter identified as glass.
SUN PHARMACEUTICAL INDUSTRIES INC · May 12, 2026
fentaNYL Citrate
Class IISubpotent Drug
IntegraDose Compounding Services LLC · May 12, 2026
Lidocaine HCl Injection USP
Class IILack of Assurance of Sterility
Spectra Medical Devices, Llc · May 12, 2026
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon…
Class IILabeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Haleon US Holdings LLC · May 11, 2026
cimzia (certolizumab pegol)
Class IILack of Assurance of Sterility
UCB Biosciences Inc. · May 8, 2026
Amlodipine and Olmesartan Medoxomil Tablets
Class IIFailed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Ascend Laboratories, LLC · May 5, 2026
Busulfan Injection
Class IIIFailed Impurities/Degradation Specifications
Sagent Pharmaceuticals · May 4, 2026
Vitamin B-Complex
Class IIPresence of a Foreign Substance; black particles observed in liquid
Safecor Health, LLC · May 1, 2026
Primidone Tablets
Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC · May 1, 2026
Primidone Tablets
Class IIICross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Amerisource Health Services LLC · May 1, 2026
Showing 40 of 1,895 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.