CLASS II Drug recall · Reported 6 Jan 2016 · FDA Enforcement Report
Clonidine Hydrochloride Tablets, USP, 0.1 mg recalled
PD-Rx Pharmaceuticals is recalling Clonidine Hydrochloride Tablets, USP, 0.1 mg, distributed in Alabama. The recall was initiated on 10 Jul 2015 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-0559-2016
- FDA event ID
- 72942
- Recalling firm
- PD-Rx Pharmaceuticals, Oklahoma City, OK
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jul 2015
- FDA classified
- 31 Dec 2015
- Reported
- 6 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Blood Pressure Medication
Timeline
| 10 Jul 2015 | Recall initiated by company | |
| 31 Dec 2015 | Classified by FDA | +174 days |
| 6 Jan 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations
Product as listed by the FDA
Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01
Where it was distributed
Alabama
Questions about this recall
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot# B14D26, Exp 02/16
Where was it sold?
Alabama
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 PD-Rx Pharmaceuticals
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DULoxetine DR USP, 30 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Nitrosamine Impurity | FL, MS, WI |
| Drug | CLASS II | Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Clonidine recalls
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clonidine Transdermal System, USP, 0.3 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS II | Clonidine Transdermal System, USP, 0.1 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS II | Clonidine Transdermal System, USP, 0.2 mg/day, supplied recalledClonidine Transdermal System | Teva Pharmaceuticals USA | Manufacturing (CGMP) Deviations | NJ |
| Drug | CLASS III | Clonidine Hydrochloride Tablets, USP, 0.3 mg recalledClonidine Hydrochloride | Unichem Pharmaceuticals USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches recalledClonidine | Mayne Pharma | Potency & Assay | Nationwide |