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
PEPCID COMPLETE
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Bayer 2Pk- 25 CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Claritin, 20 Count, UPC: 655708016305
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
NYQUIL COLD & FLU -32CT/2PK
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
LIQUID NYQUIL a) regular
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Carmex a) jar
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
PEPTO BISMOL 32CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Advil a) Ibuprofen
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Halls Cough Drops a) BAGS
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
CHILDREN NYQUIL
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Deodorant: a) Axe
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Toothpaste: a) COLGATE
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
EXCEDRIN 2'S DISP.- 30 CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Personal Care
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
LUCKY ICE, Cool Mouthwash, Alcohol Free, 16.9oz, 12CT, UPC: 808829108989
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
MOTRIN 2'S DISP.- 50CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
TUMS a) Assorted
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Aleve 1's, 60 CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Petroleum jelly: a) Vaseline Petroleum Jelly
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Personal Care
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Swan, White Clear Alcohol, 50%, 16oz, 12 count
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
EXCEDRIN MIGRAINE 2'S- 25 CT
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
LIQUID DAYQUIL 12/8oz
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
TYLENOL a) 500 MG.
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Dec 26, 2025
Sterile Water for Irrigation
Class IIPresence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Baxter Healthcare Corporation · Dec 22, 2025
INON ACE Antacid tablets (magnesium aluminosilicate
Class IIFailed Disintegration Specifications: above the time expected.
Sato Pharmaceutical Co., Ltd · Dec 19, 2025
Wegovy (semaglutide) Injection
Class IIPresence of Particulate Matter: Hair was found in a prefilled syringe
Novo Nordisk Inc. · Dec 19, 2025
Wegovy (semaglutide) Injection
Class IIPresence of Particulate Matter: Hair was found in a prefilled syringe
Novo Nordisk Inc. · Dec 19, 2025
Dexamethasone Moxifloxacin
Class IIPresence of particulate matter - Glass like particles.
Imprimis NJOF, LLC · Dec 18, 2025
Dexamethasone Moxifloxacin Ketorolac
Class IIPresence of particulate matter - Glass like particles.
Imprimis NJOF, LLC · Dec 18, 2025
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL
Class IIPresence of particulate matter - Glass like particles.
Imprimis NJOF, LLC · Dec 18, 2025
BD ChloraPrep" Triple Swabsticks (Chlorhexidine gluconate (CHG)
Class IILack of Assurance of Sterlity
CareFusion 213, LLC · Dec 17, 2025
Oxycodone and Acetaminophen CII Tablets USP
Class IIFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC · Dec 16, 2025
Oxycodone and Acetaminophen CII Tablets USP
Class IIFailed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC · Dec 16, 2025
Noxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension
Class IIPresence of particulate matter: potential presence of metal particulates in the product.
Merck Sharp & Dohme LLC · Dec 12, 2025
Merck Emend (aprepitant) for oral suspension
Class IIPresence of particulate matter: potential presence of metal particulates in the product.
Merck Sharp & Dohme LLC · Dec 12, 2025
Ciclopirox Shampoo
Class IIFailed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
SUN PHARMA /TARO · Dec 9, 2025
ORL Kids Natural Toothpaste
Class IIcGMP Deviations
Signature Formulations, LLC · Dec 8, 2025
ORL Kids Mouthwash
Class IIcGMP Deviations
Signature Formulations, LLC · Dec 8, 2025
Baclofen Tablets USP
Class IIPresence of Foreign Tablets/Capsules
Golden State Medical Supply Inc. · Nov 26, 2025
Showing 40 of 1,472 Class II recalls (1,769 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.