CLASS III Drug recall · Reported 28 Sep 2022 · FDA Enforcement Report
Clonidine Hydrochloride Tablets, USP, 0.3 mg recalled
Unichem Pharmaceuticals USA is recalling Clonidine Hydrochloride Tablets, USP, 0.3 mg, distributed nationwide in the US. The recall was initiated on 19 Sep 2022 and the FDA has classified it as Class III.
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-1541-2022
- FDA event ID
- 90709
- Recalling firm
- Unichem Pharmaceuticals USA, East Brunswick, NJ
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 19 Sep 2022
- FDA classified
- 22 Sep 2022
- Reported
- 28 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 19 Sep 2022 | Recall initiated by company | |
| 22 Sep 2022 | Classified by FDA | +3 days |
| 28 Sep 2022 | 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
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Clonidine Hydrochloride Tablets, USP, 0.3 mg, 100-count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Manufactured for: UNICHEM PHARMACEUTICALS (USA), INC. East Brunswick, NJ 08816. NDC# 29300-137-01
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Which lots are affected?
Lot # GCLH22005, exp. date 02/29/2024
Where was it sold?
Distributed Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 Unichem Pharmaceuticals USA
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|---|---|---|---|---|---|
| Drug | CLASS III | busPIRone Hydrochloride Tablets, USP, 5 mg recalledBuspirone Hydrochloride | Unichem Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS III | Doxazosin Tablets, USP, 4 mg recalled by Unichem Pharmaceuticals USADoxazosin Mesylate | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Bisoprolol Fumarate and Hydrochlorothiazide tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Unichem Pharmaceuticals USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS I | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg recalledCyclobenzaprine Hydrochloride | Unichem Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS III | Topiramate Tablets, USP 50 mg recalled by Unichem Pharmaceuticals UsaTopiramate | Unichem Pharmaceuticals USA | 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 II | Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches recalledClonidine | Mayne Pharma | Potency & Assay | Nationwide |
| Drug | CLASS II | Clonidine Hydrochloride Tablets, USP, 0.1 mg recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |