Aidarex Chlorhexidine Oral Rinse Recall: Impurity Issue
Aidarex recalls specific lots of Chlorhexidine Gluco 0.12% Oral Rinse due to failed impurity specifications. Check your lot numbers immediately.
Recall notice
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Contact the company
What happened, in plain English
Aidarex Pharmaceuticals LLC is recalling Chlorhexidine Gluco 0.12% Oral Rinse packaged in 473 mL bottles because the product failed to meet specifications for unknown impurities. The recall covers 292 bottles distributed across California, North Dakota, Pennsylvania, and Tennessee. The record does not specify what actions consumers should take or if there are known health risks associated with these impurities. Read more at govinfonow.com/recall/42596-aidarex-chlorhexidine-oral-rinse-recall-impurity-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/42596-aidarex-chlorhexidine-oral-rinse-recall-impurity-issue · Updated October 9, 2026 · FDA enforcement record: FDA #D-0975-2016
Cite this page
“Aidarex Chlorhexidine Oral Rinse Recall: Impurity Issue.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42596-aidarex-chlorhexidine-oral-rinse-recall-impurity-issue. Based on FDA recall #D-0975-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0975-2016%22&limit=1).
Why it’s dangerous
The product failed impurity/degradation specifications by containing an unknown impurity. The specific health effects or danger mechanism of this impurity are not described in the provided record.
Who’s affected
Individuals who purchased Rx-only Chlorhexidine Gluco Oral Rinse from the specified states between the manufacturing dates and the recall date. The record does not specify which patient groups are most at risk.
How to tell if you have this one
Look for Chlorhexidine Gluco 0.12% Oral Rinse in 473 mL bottles, Rx only, manufactured by Hi-Tech Pharmacal Co., Inc. and packaged by Aidarex Pharmaceuticals. Check the NDC 33261-0447-01 and one of the following lot numbers: 45335-1, 46807-1, 44359-1, 44395-1, 44693-1, 44694-1, 43707-1, 47697-1, 48605-1, 48659-1, 47772-1, or 48271-1.
- Brand
Aidarex Pharmaceuticals- Category
Drug
Where it went and when
Where it was distributed
Distributed in 4 states.
FDA distribution: “U.S. including: CA, ND, PA, TN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, North Dakota, Pennsylvania, Tennessee.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0975-2016 (June 1, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0975-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.