CLASS II Drug recall · Reported 5 Aug 2015 · FDA Enforcement Report
Clonidine Hydrochloride Tablets, USP, 0.1 mg recalled
Mutual Pharmaceutical is recalling Clonidine Hydrochloride Tablets, USP, 0.1 mg. The recall was initiated on 9 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-1280-2015
- FDA event ID
- 71684
- Recalling firm
- Mutual Pharmaceutical, Philadelphia, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jul 2015
- FDA classified
- 30 Jul 2015
- Reported
- 5 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Blood Pressure Medication
Timeline
| 9 Jul 2015 | Recall initiated by company | |
| 30 Jul 2015 | Classified by FDA | +21 days |
| 5 Aug 2015 | 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; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Product as listed by the FDA
Clonidine Hydrochloride Tablets, USP, 0.1 mg, packaged in a) 100 count (NDC 53489-215-01) and b) 1000 count (NDC 53489-215-10) HDPE bottles, Rx only, Mutual Pharmaceutical, Philadelphia, PA
Where it was distributed
Nartionwide
Questions about this recall
Why was it recalled?
cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer
Which lots are affected?
Lot #: a) 6624001 exp 2/16, 6630501 exp 3/16, 6669001 exp 12/16, 6676201 exp 1/17, 6680701 exp 2/17; b) 6624002, 6624201 exp 2/16, 6630601 exp 3/16, 6668901 exp 12/16, 6676001, 6676101 exp 1/17, 6679401, 6679501, exp 2/17
Where was it sold?
Nartionwide
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.
Other products in this recall event
2 other products · FDA event 71684This product is part of a recall event; the main page for the event is Clonidine Hydrochloride Tablets, USP, 0.3 mg HDPE recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Clonidine Hydrochloride Tablets, USP, 0.3 mg HDPE recalled | Mutual Pharmaceutical | Manufacturing (CGMP) Deviations | PA | |
| CLASS II | Clonidine Hydrochloride Tablets, USP, 0.2 mg recalled | Mutual Pharmaceutical | Manufacturing (CGMP) Deviations | PA |
More recalls from Mutual Pharmaceutical
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets recalled | Mutual Pharmaceutical | Other | MS |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 10 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 25 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Imipramine HCl Tablets, USP, 50 mg recalled | Mutual Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Felodipine Extended-Release Tablets, 5 mg recalled | Mutual Pharmaceutical | Other | 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 |