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
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc. · Nov 24, 2025
Duloxetine Delayed-Release Capsules
Class IICGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Breckenridge Pharmaceutical, Inc. · Nov 24, 2025
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5% Topical Ophth…
Class IIIncorrect Product Formulation
Fagron Compounding Services · Nov 20, 2025
Ondansetron ODT Tablets
Class IIDefective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Preferred Pharmaceuticals, Inc. · Nov 17, 2025
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA, Inc. · Nov 14, 2025
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA, Inc. · Nov 14, 2025
Cinacalcet Hydrochloride Tablets
Class IICGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cipla USA, Inc. · Nov 14, 2025
Ganirelix Acetate Injection
Class IIFailed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Lupin Pharmaceuticals Inc. · Nov 13, 2025
Walgreens Saline Nasal Spray WITH XYLITOL
Class IIMicrobial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Medical Products Laboratories, Inc. · Nov 12, 2025
Sertraline Hydrochloride Tablets USP
Class IIDefective container - seal not adhering to bottles
Lupin Pharmaceuticals Inc. · Nov 5, 2025
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corpo…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dy…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Lidocaine HCI 2% and Epinephrine 1:100
Class IIDefective container: cracked/broken cartridges
Novocol Pharmaceutical of Canada, Inc. · Oct 31, 2025
Cook-Walte, Carbocaine 3% (30 mg/mL), (mepivacaine hydrochloride Injection, USP)…
Class IIDefective container: cracked/broken cartridges
Novocol Pharmaceutical of Canada, Inc. · Oct 31, 2025
Globe Clotrimazole Cream USP
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, In…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a carton…
Class IIDefective container: cracked/broken cartridges
Novocol Pharmaceutical of Canada, Inc. · Oct 31, 2025
Lanashield Skin Barrier
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
2% Xylocaine DENTAL with Epinephrine 1:100
Class IIDefective container: cracked/broken cartridges
Novocol Pharmaceutical of Canada, Inc. · Oct 31, 2025
Globe Clotrimazole Cream
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Phytonadione Injectable Emulsion
Class IIFailed Stability Specifications: Observed OOS results: eg results for colour index
Cipla Limited · Oct 31, 2025
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivage…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
3% Polocaine DENTAL
Class IIDefective container: cracked/broken cartridges
Novocol Pharmaceutical of Canada, Inc. · Oct 31, 2025
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glensh…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
darby dental supply
Class IIDefective container: cracked/broken cartridges
Novocol Pharmaceutical of Canada, Inc. · Oct 31, 2025
Wecare Calasoothe
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Benco dental Graham CHEMICAL CO.
Class IIDefective container: cracked/broken cartridges
Novocol Pharmaceutical of Canada, Inc. · Oct 31, 2025
Wecare Enema
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Dynashield Skin Protectant
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Nivagen Pharmaceuticals
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC · Oct 28, 2025
Agebox iKids-Growth (Day Formula) capsules
Class IIMarketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Agebox · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC · Oct 28, 2025
Agebox iKids-Growth (Night Formula)
Class IIMarketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Agebox · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC · Oct 28, 2025
Lisdexamfetamine Dimesylate Capsules
Class IIFailed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.
SUN PHARMACEUTICAL INDUSTRIES INC · Oct 28, 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.