CLASS II Drug recall · Reported 30 Jan 2013 · FDA Enforcement Report
Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg recalled
West-ward Pharmaceutical is recalling Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, distributed nationwide in the US. The recall was initiated on 30 Nov 2012 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-132-2013
- FDA event ID
- 63967
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Nov 2012
- FDA classified
- 18 Jan 2013
- Reported
- 30 Jan 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Blood Pressure Medication
Timeline
| 30 Nov 2012 | Recall initiated by company | |
| 18 Jan 2013 | Classified by FDA | +49 days |
| 30 Jan 2013 | 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 Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Product as listed by the FDA
Lisinopril and Hydrochlorothiazide Tablets, 20 mg/25 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1264-01) and b) 1000-count tablets per bottle (NDC 0143-1264-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.
Which lots are affected?
Lot #: 69392A, 69393A, 69394A, 69395A, 69396A, 69397A , Exp 09/15; 69495A, 69496A, 69497A, 69498A, 69524A, 69525A, Exp 10/15
Where was it sold?
Nationwide and Puerto Rico
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.
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Other Lisinopril recalls
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg recalledLisinopril And Hydrochlorothiazide | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Lisinopril Tablets, USP 10 mg recalled by Evaric PharmaceuticalsLisinopril | Evaric Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg recalledLisinopril And Hydrochlorothiazide | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lisinopril Tablets USP, 10 mg recalled by Lupin PharmaceuticalsLisinopril | Lupin Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Lisinopril Tablets USP, 10 mg recalled by Lupin PharmaceuticalsLisinopril | Lupin Pharmaceuticals | Other | Nationwide |