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
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
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, M…
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 Flavo…
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
VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams Act…
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 Acti…
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 Act…
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
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.