CLASS II Drug recall · Reported 15 Jun 2016 · FDA Enforcement Report
Chlorhexidine Gluco recalled by Aidarex Pharmaceuticals
Aidarex Pharmaceuticals is recalling Chlorhexidine Gluco, distributed in California, North Dakota, Pennsylvania, Tennessee. The recall was initiated on 1 Jun 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0975-2016
- FDA event ID
- 74315
- Recalling firm
- Aidarex Pharmaceuticals, Corona, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jun 2016
- FDA classified
- 8 Jun 2016
- Reported
- 15 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- FAX
- Reason category
- Potency & Assay
Timeline
| 1 Jun 2016 | Recall initiated by company | |
| 8 Jun 2016 | Classified by FDA | +7 days |
| 15 Jun 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
Where it was distributed
U.S. including: CA, ND, PA, TN
Questions about this recall
Why was it recalled?
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Which lots are affected?
Lot #: 45335-1, Expiry: 2017/02; Lot #: 46807-1, Expiry: 2017/01; Lot #: 44359-1, Expiry: 2017/02; Lot #: 44395-1, Expiry: 2017/02; Lot #: 44693-1, Expiry: 2017/02; Lot #: 44694-1, Expiry: 2017/02; Lot #: 43707-1, Expiry: 2017/03; Lot #: 47697-1, Expiry: 2017/03; Lot #: 48605-1, Expiry: 2017/03; Lot #: 48659-1, Expiry: 2017/03; Lot #: 47772-1, Expiry: 2017/05; Lot #: 48271-1, Expiry: 2017/05.
Where was it sold?
U.S. including: CA, ND, PA, TN
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aidarex Pharmaceuticals
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate, USP 2.5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Ferrous Sulfate recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Other | FL |
| Drug | CLASS III | Enalapril Maleate Tablets, USP, 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | FL |