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
Focalin XR (dexmethylphenidate HCl) 5 mg
Class IIILabeling: Incorrect or Missing Lot and/or Exp Date
Sandoz Inc · Jun 1, 2026
BEEKEEPER'S NATURALS Saline Nasal Spray
Class IMicrobial Contamination of Non-Sterile Products
BEEKEEPER'S NATURALS USA INC. · Jun 1, 2026
Minocycline Hydrochloride Extended-Release Tablets
Class IIFailed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Ascend Laboratories, LLC · Jun 1, 2026
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Gasco Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Gasco Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
Gasco Isopropyl Alcohol 70%
Class IISubpotent drug
Gasco Industrial Corp. · May 29, 2026
GSMS Incorporated
Class IIFailed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
Golden State Medical Supply Inc. · May 29, 2026
Budesonide Inhalation Suspension
Class IIPresence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
SUN PHARMACEUTICAL INDUSTRIES INC · May 29, 2026
BD ChloraPrep FREPP Clear
Class INon-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
CareFusion 213, LLC · May 28, 2026
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl…
Class INon-Sterility: Due to presence of Aspergillus penicillioides.
CareFusion 213, LLC · May 28, 2026
BD ChloraPrep FREPP Clear
Class IILack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
CareFusion 213, LLC · May 28, 2026
Fenofibrate Capsules
Class IICGMP Deviations
Ajanta Pharma USA Inc · May 28, 2026
BD ChloraPrep Clear
Class IILack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
CareFusion 213, LLC · May 28, 2026
KIRKLAND Signature
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
FAMILY WELLNESS
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Good Neighbor Pharmacy
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Harris Teeter
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
H.E.B Extra Strength Calcium Carbonate Antacid Tablets
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
24/7 life BY 7-ELEVEN
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
MARKET BASKET ANTACID Calcium Carbonate 1000 mg
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
FAMILY WELLNESS
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
TopCare health
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Extra strength Antacid Calcium Carbonate 750 mg
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
Good Neighbor Pharmacy
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
EQUALINE extra strength
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
GOODSENSE Extra Strength
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
EQUALINE ultra strength
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewable…
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
DISCOUNT drug mart
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
GOODSENSE Ultra Strength
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
TopCare health
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS, DI…
Class IIPresence of foreign substance: small metallic particles in chewable tablets.
Guardian Drug Co. Inc. · May 28, 2026
CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewable T…
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, D…
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
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.