CLASS II Drug recall · Reported 20 Jan 2016 · FDA Enforcement Report
Hydrochlorothiazide Capsules, USP, 12.5 mg, 10 cap/blister recalled
Amerisource Health Services is recalling Hydrochlorothiazide Capsules, USP, 12.5 mg, 10 cap/blister, distributed nationwide in the US. The recall was initiated on 29 Oct 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-0565-2016
- FDA event ID
- 72865
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Oct 2015
- FDA classified
- 8 Jan 2016
- Reported
- 20 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Blood Pressure Medication
Timeline
| 29 Oct 2015 | Recall initiated by company | |
| 8 Jan 2016 | Classified by FDA | +71 days |
| 20 Jan 2016 | Published in enforcement report | +12 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 Particulate Matter
Product as listed by the FDA
HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter
Which lots are affected?
Lot # 151379 and Lot #151380; Exp 12/16
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 Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | 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 recalled | Vintage Pharmaceuticals LLC | Particulate Matter | Nationwide |
| Drug | CLASS II | Hydrochlorothiazide Tablet USP 25 mg recalledHydrochlorothiazide | Unichem Pharmaceuticals Usa | Other | Nationwide |