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Manufacturer profile

AvKARE

Pharmaceutical company18 products tracked
18
products tracked
492,099
total reports
61
recalls on record
64.6%
serious overall
Products
showing 18 of 18
ProductApprovedReports ↓Top signalRecalls
200679,359Abnormal dreams0
200169,168Pregnancy with implant contraceptive0
200652,242Blood prolactin increased5
201743,131Sprue-like enteropathy15
201740,089Idiopathic pulmonary fibrosis2
200733,035Bradycardia0
—22,046Hypercoagulation0
200121,862Sleep disorder due to a general medical condition23
198721,038Blood bilirubin increased0
200118,444Cytomegalovirus viraemia0
200118,444Cytomegalovirus viraemia0
—17,015Blood pressure inadequately controlled0
200715,403Palmar-plantar erythrodysaesthesia syndrome0
197910,411Methaemoglobinaemia5
200910,054Amaurosis fugax6
200910,002Amaurosis fugax0
—7,394Sprue-like enteropathy3
20062,962Heart rate decreased2
Recall history · 50 on record
DateClassReasonFirm
Feb 13, 2026IIFailed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.AvKARE
Feb 3, 2026IIIPresence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mgAnnora Pharma Private Limited
Dec 31, 2025IIOut of specification for dissolution.AvKARE
Sep 2, 2025IIFailed Content Uniformity SpecificationsAvKARE
Jun 26, 2025IIIFailed Impurity/Degradation SpecificationsAvKARE
Jun 26, 2025IIIFailed Impurity/Degradation SpecificationsAvKARE
Jun 11, 2025IIIFailed Impurities/Degradation Specifications.Orient Pharma Co., Ltd. Yunlin Plant
Jun 11, 2025IIIFailed Impurities/Degradation Specifications.Orient Pharma Co., Ltd. Yunlin Plant
May 13, 2025IIPresence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsulesAvKARE
May 9, 2025IIFailed Dissolution SpecificationsAvKARE
Feb 4, 2025IISubpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)AvKARE
Jan 21, 2025IIOut of Specification for DissolutionAvKARE
Dec 18, 2024IIILABELING: LABEL MIX-UPAvKARE
Dec 18, 2024IIILABELING: LABEL MIX-UPAvKARE
Dec 10, 2024IICrystallizationVIONA PHARMACEUTICALS INC
Dec 10, 2024IICrystallizationVIONA PHARMACEUTICALS INC
Dec 4, 2024IIFailed Dissolution SpecificationsAvKARE
Nov 27, 2024IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.AvKARE
Nov 27, 2024IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.AvKARE
Nov 27, 2024IICGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.AvKARE
Oct 29, 2024IICrystallizationVIONA PHARMACEUTICALS INC
Oct 18, 2024IILabeling: Label Mix-UpAvKARE
Oct 18, 2024IILabeling: Label Mix-UpAvKARE
Sep 24, 2024IICrystallizationVIONA PHARMACEUTICALS INC
Mar 28, 2024IMicrobial contamination of a non-sterile product: potential Bacillus cereus contamination.AvKARE
Aug 11, 2023IICases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental ToothpasteAVKARE LLC
Aug 11, 2023IIProduct mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental ToothpasteAVKARE LLC
Feb 7, 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
Feb 7, 2023IICGMP Deviations: recalling drug products following an FDA inspection.Accord Healthcare, Inc.
Dec 22, 2022IIFailed impurities/degradation specifications: Out of specification for unknown impurities.AVKARE LLC
Dec 22, 2022IILack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.Pharmacy Innovations
Jul 20, 2022IIILabeling: Label Error on Declared StrengthAVKARE Inc.
Feb 28, 2022IIFailed Dissolution SpecificationsThe Harvard Drug Group
Oct 12, 2021IILack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021IILack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy
Oct 12, 2021IILack of assurance of sterilityVita Pharmacy, LLC dba Talon Compounding Pharmacy
Jun 9, 2021IIIFailed Impurities Specification: Out of specification when measuring the impurity degradant D level.AVKARE Inc.
Apr 29, 2021IIIPresence of Foreign Tablet/CapsuleAscend Laboratories LLC
Mar 15, 2021IICGMP Deviations: Intermittent exposure to temperature excursion during storage.Cardinal Health Inc.
Dec 7, 2020IIProduct mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.AVKARE Inc.
Oct 30, 2020IIFailed Dissolution SpecificationsAVKARE Inc.
Jun 4, 2020IICGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelAVKARE Inc.
Jun 4, 2020IICGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake levelAVKARE Inc.
May 28, 2020IIIPresence of Foreign Substance consistent with granules from desiccant packs used during storageAVKARE Inc.
Jan 24, 2020IIcGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.Ascend Laboratories LLC
Jan 7, 2020IIFailed Impurities/Degradation Specifications: High out of specification results for related compounds.AVKARE Inc.
Nov 14, 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.
Nov 14, 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.
Oct 17, 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.
Oct 17, 2019IICGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in APIAVKARE Inc.

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm.

Registration status

Some products from AvKARE are not FDA-registered for human use. For unregistered substances (peptides, SARMs without human registration), no legitimate human-use supplier exists. The absence of a sourcing route is the safety information.