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
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
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
Bromocriptine Mesylate Capsules
Class IIFailed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Zydus Pharmaceuticals (USA) Inc · Oct 23, 2025
clomiPRAMINE Hydrochloride
Class IIcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Zydus Pharmaceuticals (USA) Inc · Oct 22, 2025
clomiPRAMINE Hydrochloride
Class IIcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Zydus Pharmaceuticals (USA) Inc · Oct 22, 2025
clomiPRAMINE Hydrochloride
Class IIcGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
Zydus Pharmaceuticals (USA) Inc · Oct 22, 2025
Opdualag (nivolumab and relatlimab-rmbw) injection
Class IILack of Assurance of Sterility.
Bristol-Myers Squibb Company · Oct 21, 2025
TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by…
Class IIDefective Container
Kenvue Brands LLC · Oct 21, 2025
NIACIN Extended-Release Tablets
Class IIFailed Dissolution Specifications
Golden State Medical Supply Inc. · Oct 20, 2025
Acetaminophen 500mg Caffeine 65mg caplets
Class IILabeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
Aero Healthcare · Oct 17, 2025
Prazosin Hydrochloride
Class IIFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Amerisource Health Services LLC · Oct 16, 2025
Prazosin Hydrochloride
Class IIFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Amerisource Health Services LLC · Oct 16, 2025
Prazosin Hydrochloride
Class IIFailed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit
Amerisource Health Services LLC · Oct 16, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
Semaglutide Injection
Class IILack of Assurance of Sterility
ProRx LLC · Oct 15, 2025
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.