CLASS II Drug recall · Reported 8 Jan 2014 · FDA Enforcement Report
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg recalled
Sandoz is recalling Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, distributed nationwide in the US. The recall was initiated on 11 Oct 2013 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-393-2014
- FDA event ID
- 66554
- Recalling firm
- Sandoz, Wilson, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Oct 2013
- FDA classified
- 30 Dec 2013
- Reported
- 8 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 11 Oct 2013 | Recall initiated by company | |
| 30 Dec 2013 | Classified by FDA | +80 days |
| 8 Jan 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent; Hydrochlorothiazide at the 9 month time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
Where it was distributed
Nationwide
Questions about this recall
Is Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg recalled?
Yes. Sandoz recalled Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg on 11 Oct 2013. The recall is Class II and its status is Terminated. Recall number D-393-2014.
Why was it recalled?
Subpotent; Hydrochlorothiazide at the 9 month time point.
Which lots are affected?
Lot CU0856
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 21 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 Sandoz
All 43| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Sterility | Nationwide |
| Drug | CLASS II | Ciprofloxacin 3% and Dexamethasone 1% Otic Suspension recalled by SandozCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Sterility | Nationwide |