Drug Recalls
Recent drug recall reports from the FDA (US) and Health Canada, newest first. Each entry links to the full record -- product description, reason for recall, and severity classification -- refreshed daily.
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 6…
Agebox
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Agebox
Marketed Without an Approved NDA/ANDA: presence of undeclared ibutamoren
Otsuka ICU Medical LLC
Lack of Assurance of Sterility: Potential for flexible container leaks.
JAMP SERTRALINE 50mg
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
Cipla USA, Inc.
Failed stability specifications: Out of specification for hardness test
Cipla USA, Inc.
Failed stability specifications: Out of specification for hardness test
Zydus Pharmaceuticals (USA) Inc
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.
Zydus Pharmaceuticals (USA) Inc
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acc…
Zydus Pharmaceuticals (USA) Inc
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acc…
Zydus Pharmaceuticals (USA) Inc
cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acc…
Bristol-Myers Squibb Company
Lack of Assurance of Sterility.
Kenvue Brands LLC
Defective Container
Golden State Medical Supply Inc.
Failed Dissolution Specifications
Imprimis NJOF, LLC
Subpotent Drug
ANTHONY TRINH, 123Herbals LLC
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
Aero Healthcare
Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The in…
Amerisource Health Services LLC
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable …
Amerisource Health Services LLC
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable …
Amerisource Health Services LLC
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable …
Isologic Innovative Radiopharmaceuticals Products
Labelling. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health concerns…
ProRx LLC
Lack of Assurance of Sterility
ProRx LLC
Lack of Assurance of Sterility
ProRx LLC
Lack of Assurance of Sterility
ProRx LLC
Lack of Assurance of Sterility