CLASS II Drug recall · Reported 22 Aug 2018 · FDA Enforcement Report
Lisinopril Tablets USP, 10mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Lisinopril Tablets USP, 10mg, distributed nationwide in the US. The recall was initiated on 13 Aug 2018 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-1077-2018
- FDA event ID
- 80789
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Lisinopril
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Aug 2018
- FDA classified
- 13 Aug 2018
- Reported
- 22 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 13 Aug 2018 | Recall initiated by company | |
| 13 Aug 2018 | Classified by FDA | +0 days |
| 22 Aug 2018 | 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
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Lisinopril Tablets USP, 10mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202, NDC 68180-980-03
Where it was distributed
Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.
Questions about this recall
Is Lisinopril Tablets USP, 10mg recalled?
Yes. Lupin Pharmaceuticals recalled Lisinopril Tablets USP, 10mg on 13 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-1077-2018.
Why was it recalled?
Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Which lots are affected?
Lot #: H800414, Exp. 12/2019
Where was it sold?
Product was distributed to distributors, mail order pharmacy and supermarkets throughout the United States.
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.
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Other Lisinopril recalls
All 34| 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 |