CLASS II Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report
Hydrochlorothiazide Tablet USP 25 mg recalled
Unichem Pharmaceuticals Usa is recalling Hydrochlorothiazide Tablet USP 25 mg, distributed nationwide in the US. The recall was initiated on 30 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-1352-2015
- FDA event ID
- 71860
- Recalling firm
- Unichem Pharmaceuticals Usa, Rochelle Park, NJ
- Brand
- Hydrochlorothiazide
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jul 2015
- FDA classified
- 25 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 30 Jul 2015 | Recall initiated by company | |
| 25 Aug 2015 | Classified by FDA | +26 days |
| 2 Sep 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Product as listed by the FDA
Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Which lots are affected?
Lot #: GHYL15028, Exp April 2018
Where was it sold?
Nationwide
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 Unichem Pharmaceuticals Usa
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 | Clonidine Hydrochloride Tablets, USP, 0.3 mg recalledClonidine Hydrochloride | Unichem Pharmaceuticals USA | Packaging Defects | Nationwide |
Other Hydrochlorothiazide recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrochlorothiazide 50mg tablets recalled by Calvin Scott & Company | Calvin Scott | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide 25mg tablets recalled by Calvin Scott & Company | Calvin Scott | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Hydrochlorothiazide Tablets USP, 12.5 mg recalled by Accord HealthcareHydrochlorothiazide | Accord Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide Capsules, USP, 12.5 mg, 10 cap/blister recalled | Amerisource Health Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide Capsules, USP, 12.5 mg recalled | Vintage Pharmaceuticals LLC | Particulate Matter | Nationwide |