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
Cinacalcet Tablets
Class IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKARE · Nov 27, 2024
Cinacalcet Tablets
Class IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKARE · Nov 27, 2024
Cinacalcet Tablets
Class IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
AvKARE · Nov 27, 2024
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Class IILack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Curium US, LLC · Nov 26, 2024
Olanzapine Tablets
Class IIFailed Impurities/Degradation Specifications
Macleods Pharmaceuticals Ltd · Nov 25, 2024
VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net…
Class IICGMP deviations: out of specifications for assay
Apothecus Pharmaceutical Corp. · Nov 22, 2024
10 Irregular Pigmentation
Class IICGMP Deviations: Inconsistency in the water systems.
Generitech Corporation · Nov 22, 2024
Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection
Class IIFailed Stability Specifications
Jubilant Draximage Inc., dba Jubilant Radiopharma · Nov 22, 2024
Dihydroergotamine Mesylate Injection
Class IIDiscoloration
Provepharm Inc. · Nov 22, 2024
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma Holding, Inc. · Nov 19, 2024
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma Holding, Inc. · Nov 19, 2024
Duloxetine DR Capsules USP 60 mg
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Rising Pharma Holding, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets
Class IISubpotent and Superpotent Drug
Mylan Institutional, Inc. · Nov 19, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Levothyroxine Sodium Tablets USP
Class IISuperpotent Drug and Subpotent Drug: potency failures obtained
Viatris Inc · Nov 18, 2024
Lisinopril Tablets
Class IIPresence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Evaric Pharmaceuticals Inc. · Nov 15, 2024
Patterson Dental
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30…
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Amerisource Health Services LLC · Nov 14, 2024
UMARY ACID HYALURONIC
Class IIcGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
MXBBB · Nov 14, 2024
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
M&S Dental Supply Co LLC.
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Pearson Quality
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten…
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6…
Class IICGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries · Nov 14, 2024
Kirkland Severe Cold & Flu Plus Congestion: Day
Class IICGMP Deviations: Released product should have been rejected.
LNK International, Inc. · Nov 14, 2024
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.