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
Irbesartan Tablets USP
Class IIOut of Specification for Dissolution
AvKARE · Jan 21, 2025
Lorazepam Tablets
Class IIFailed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Jan 21, 2025
Phenylephrine HCl Injection
Class IPresence of Particulate Matter.
Provepharm Inc. · Jan 21, 2025
Lorazepam Tablets
Class IIFailed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Jan 21, 2025
Inflectra (infliximab-dyyb)
Class IIcGMP Deviations: Product intended for quarantine was inadvertently distributed.
McKesson · Jan 17, 2025
BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC, (uncoated 25% zinc…
Class IIILabeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
The W.S. Badger Company, Inc. · Jan 17, 2025
Venlafaxine Extended-Release Tablets
Class IIIFailed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Appco Pharma LLC · Jan 16, 2025
Duloxetine Delayed-Release Capsules USP
Class IICGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Jan 13, 2025
Granix (tbo-filgrastim) Injection 300 mcg/0.5 mL
Class IIFailed Stability Specifications - 12-month stability test result for one of the known peptides is below the specification limit
Teva Pharmaceuticals USA, Inc · Jan 10, 2025
babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%…
Class IIFailed stability specifications: during routine stability monitoring quality concerns were identified. Physical separation for ingredients was observed.
Johnson, S C and Son, Inc · Jan 8, 2025
Clobazam Tablets
Class IIPresence of Foreign Tablets/Capsules
Amerisource Health Services LLC · Jan 7, 2025
Guaifenesin and Codeine Phosphate Oral Solution USP
Class IIISuperpotent; sodium benzoate preservative
PAI Holdings, LLC. dba Pharmaceutical Associates Inc · Jan 7, 2025
Duloxetine Delayed-Release Capsules USP 20 mg
Class IICGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Dec 30, 2024
Metformin Hydrochloride Extended-Release Tablets
Class IIPresence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
Granules Pharmaceuticals Inc. · Dec 30, 2024
Duloxetine DR Capsules USP 60 mg
Class IICGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Dec 30, 2024
Duloxetine Delayed-Release Capsules USP 30 mg
Class IICGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Rising Pharma Holding, Inc. · Dec 30, 2024
Progesterone Injection USP
Class IIPresence of Particulate Matter: A market complaint was received of a glass piece in the vial.
Eugia US LLC · Dec 27, 2024
Astagraf XL (tacrolimus extended-release capsules) 0.5 mg
Class IFailed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas Pharma US Inc. · Dec 23, 2024
Cardura XL (doxazosin) extended release tablets 4 mg
Class IIFailed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Inc · Dec 23, 2024
Cardura XL (doxazosin) extended release tablets 8 mg
Class IIFailed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Viatris Inc · Dec 23, 2024
Prograf (tacrolimus) capsules
Class IFailed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules
Astellas Pharma US Inc. · Dec 23, 2024
First Aid Beauty Ultra Repair Cream
Class IICGMP Deviations; product intended for quarantine was inadvertently distributed
First Aid Beauty Ltd · Dec 23, 2024
Adrenalin Chloride Solution (Epinephrine Nasal Solution
Class ILabeling: Not Elsewhere Classified: misleading label similar in appearance to the FDA-approved drug product Adrenalin¿ (epinephrine injection, USP)
ENDO USA, Inc. · Dec 20, 2024
Levothyroxine Sodium Tablets
Class IIFailed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Lupin Pharmaceuticals Inc. · Dec 20, 2024
phenylephrine in 0.9% Sodium Chloride Inj
Class IILack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Hikma Injectables USA Inc · Dec 19, 2024
ketamine inj 50 mg per 1 mL
Class IILack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Hikma Injectables USA Inc · Dec 19, 2024
Methadone Hydrochloride Tablets
Class IIIFailed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
West-Ward Columbus Inc · Dec 19, 2024
Polyvinyl Alcohol Ophthalmic Solution 1.4%
Class IIILABELING: LABEL MIX-UP
AvKARE · Dec 18, 2024
medroxyPROGESTERone Acetate Injectable Suspension
Class IICGMP Deviations
Eugia US LLC · Dec 18, 2024
Systane Lubricant Eye Drops
Class INon-Sterility
Alcon Research LLC · Dec 18, 2024
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Ey…
Class IIILABELING: LABEL MIX-UP
AvKARE · Dec 18, 2024
Colchicine Capsules 0.6 mg
Class IIFailed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
Granules Pharmaceuticals Inc. · Dec 18, 2024
glipiZIDE, Extended-Release Tablets, 2.5 mg, 30-count (3x10 blister cards) carto…
Class IIFailed Dissolution Specifications:
Amerisource Health Services LLC · Dec 17, 2024
Atropine Sulfate Ophthalmic Solution
Class IIIFailed Impurities/Degradation Specifications
SOMERSET THERAPEUTICS LLC · Dec 16, 2024
FOUZEE SugarLin HERBAL FORMULA capsules
Class IMarketed without an Approved NDA/ANDA; FDA laboratory analysis confirmed product tainted with undeclared metformin and glyburide
SHOPPERS- PLAZA · Dec 16, 2024
Ciprofloxacin Ophthalmic Solution USP
Class IIDefective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
FDC Limited · Dec 16, 2024
Clobazam Tablets
Class IIPresence of Foreign Tablets/Capsules
Amerisource Health Services LLC · Dec 13, 2024
FORCE FOREVER 400mg Tablets
Class IMarketed without an approved NDA/ANDA. FDA analysis found the product to be tainted with Diclofenac and Dexamethasone.
GNMart LLC · Dec 12, 2024
Acetaminophen Extra Strength 500 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
Acetaminophen Extra Strength 500 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Dec 12, 2024
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.