FDA company announcement
AVpak: Atovaquone Oral Suspension, USP 750mg/5mL
Potential Bacillus cereus contamination
Not suppliedPublished notice; closure not supplied
Distribution: Not supplied
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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. Source coverage and dates.
Records and reported status
Official source for AVpak: Atovaquone Oral Suspension, USP 750mg/5mL
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...
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 IIReported terminated
Distribution: Affected product was distributed to nineteen (19) consignees within the united states.
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
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class IIReported terminated
Distribution: Affected product was distributed to nineteen (19) consignees within the united states.
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
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class IIIReported ongoing
Distribution: Nationwide in the USA.
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
Failed impurities/degradation specifications: Out of specification for unknown impurities.
Class IIReported completed
Distribution: USA Nationwide
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 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 and the agency's current notices.
Where can I find older records?
Use monthly 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.