CLASS II Drug recall · Reported 30 Jan 2013 · FDA Enforcement Report
Lisinopril Tablets, USP 40 mg recalled by West-ward Pharmaceutical
West-ward Pharmaceutical is recalling Lisinopril Tablets, USP 40 mg, distributed nationwide in the US. The recall was initiated on 7 Dec 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-130-2013
- FDA event ID
- 63871
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 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
| 7 Dec 2012 | Recall initiated by company | |
| 18 Jan 2013 | Classified by FDA | +42 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: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
Product as listed by the FDA
Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC 24658-245-10); Rx only, Manufactured for: Blu Pharmaceuticals, Franklin, KY 42134; Manufactured By: West-ward Pharmaceutical Corp., Eatontown, N.J. 07724.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Uncharacteristic black spots identified as a food grade lubricant with trace amounts of foreign particulates and stainless steel inclusions have been found in the tablets.
Which lots are affected?
Lot #: a) and b) 69545A, 69546A, 69546B, Exp 10/15; 69547A, Exp 11/15; 69995A, 69999A, 69999B, 70000A, 70001A, 70002A, 70002B, 70003A, 70004A, Exp 02/16; c) 69548A, 69549A, Exp 11/15; 69877A, Exp 02/16
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.
Other products in this recall event
1 other product · FDA event 63871| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Propylthiouracil Tablets, USP, 50 mg recalled | West-ward Pharmaceutical | Packaging Defects | Nationwide |
More recalls from West-ward Pharmaceutical
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | PredniSONE Tablets USP, 1 mg recalled by West-Ward PharmaceuticalPrednisone | West-Ward Pharmaceutical | Other | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) (0.05 mg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS III | Fentanyl Citrate Inj., USP, CII, 250 mcg/ (50 mcg/mL) recalledFentanyl Citrate | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
| Drug | CLASS II | Versapharm Incorporated Ethambutol Hydrochloride Tablets recalled | West-Ward Pharmaceutical | Potency & Assay | GA |
| Drug | CLASS II | Isoniazid Tablets, USP, 300 mg recalled by West-Ward Pharmaceutical | West-Ward Pharmaceutical | Potency & Assay | Nationwide |
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 Pharmaceuticals | Lupin Pharmaceuticals | Other | Nationwide |