--- title: "AVKARE LLC Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search AVKARE LLC recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/avkare-llc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # AVKARE LLC recall records **1** reported ongoing 5 records in this archive. Latest source date Apr 1, 2024. 1 published notices do not supply a closure status. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Apr 1, 2024 FDA company announcement ### [AVpak: Atovaquone Oral Suspension, USP 750mg/5mL](https://isitonrecall.com/recall/fdapress-96ba83b28934370e-avpak-atovaquone-oral-suspension-usp-750mg-5ml/) Potential Bacillus cereus contamination Not supplied Published notice; closure not supplied Distribution: Not supplied [Official source for AVpak: Atovaquone Oral Suspension, USP 750mg/5mL](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due) Aug 11, 2023 FDA drug enforcement ### [Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearmint NET WT. 1.8 OZ. (51g), Rx only, NDC 42291-741-51, Man...](https://isitonrecall.com/recall/fda-drug-d-1146-2023-sodium-fluoride-1-1-sodium-fluoride-prescription-dental-toothpaste-5000-ppm-fluoride-plus-mild-clean/) Cases 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 Toothpaste Class II Reported terminated Distribution: Affected product was distributed to nineteen (19) consignees within the united states. [Official source for Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1146-2023%22) Aug 11, 2023 FDA drug enforcement ### [Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manufactured for: AvKARE, Pulaski, TN 38478](https://isitonrecall.com/recall/fda-drug-d-1147-2023-capsaicin-cream-0-025-external-analgesic-cream-penetrating-pain-relief-net-wt-2-1-oz-60g-ndc-50268-1/) Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste Class II Reported terminated Distribution: Affected product was distributed to nineteen (19) consignees within the united states. [Official source for Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1147-2023%22) Jun 13, 2023 FDA drug enforcement ### [Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13](https://isitonrecall.com/recall/fda-drug-d-0875-2023-tranexamic-acid-usp-tablets-650-mg-30-tablets-3x10-unit-dose-rx-only-manufactured-for-avkare-pulaski/) Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class III Reported ongoing Distribution: Nationwide in the USA. [Official source for Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKA...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0875-2023%22) Dec 22, 2022 FDA drug enforcement ### [Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15](https://isitonrecall.com/recall/fda-drug-d-0091-2023-glycopyrrolate-tablets-usp-1-mg-50-tablets-5x10-unit-dose-carton-rx-only-manufactured-for-avkare-pul/) Failed impurities/degradation specifications: Out of specification for unknown impurities. Class II Reported completed Distribution: USA Nationwide [Official source for Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for:...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0091-2023%22) ## Reasons in these listed records - Potential Bacillus cereus contamination - Cases 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 Toothpaste - Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste - Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. These examples come from this result page and are not a ranking of every recall reason. ## Checking AVKARE LLC ### Is there a recall on avkare llc right now? This archive contains 5 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search AVKARE LLC](https://isitonrecall.com/check/?q=AVKARE%20LLC) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)