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
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
Varenicline Tablets
Class IIISub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Dr. Reddy's Laboratories, Inc. · Nov 11, 2025
Carton label: Testosterone Gel 1%
Class IIIDefective Container - A defect in the side-seal which allows leakage of product.
Teva Pharmaceuticals USA, Inc · Nov 7, 2025
Famotidine Injection
Class IMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Fresenius Kabi USA, LLC · Nov 6, 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…
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for…
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…
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), Pharmaceuticals, Inc.…
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, 20 %, Net Wt. 1 oz. (28.4g), Pharmaceuticals…
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…
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 20% Skin Protectant
Class IIcGMP deviations
Blossom Pharmaceuticals · Oct 31, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Otsuka ICU Medical LLC · Oct 29, 2025
POTASSIUM CHLORIDE Inj.
Class ILabeling: Label Error on Declared Strength-The overwrap label may incorrectly identify the product as POTASSIUM CHLORIDE Inj. 10 mEq instead of POTASSIUM CHLORIDE Inj. 20 mEq
Otsuka ICU Medical LLC · Oct 29, 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
0.9% SODIUM CHLORIDE Injection
Class IILack of Assurance of Sterility: Potential for flexible container leaks.
Otsuka ICU Medical LLC · Oct 27, 2025
Lanthanum Carbonate chewable tablets
Class IIFailed stability specifications: Out of specification for hardness test
Cipla USA, Inc. · Oct 24, 2025
Lanthanum Carbonate chewable tablets
Class IIFailed stability specifications: Out of specification for hardness test
Cipla USA, Inc. · Oct 24, 2025
Showing 40 of 1,895 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.