CLASS II Drug recall · Reported 21 Sep 2022 · FDA Enforcement Report
Lisinopril Tablets USP, 10 mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Lisinopril Tablets USP, 10 mg, distributed nationwide in the US. The recall was initiated on 13 Sep 2022 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-1536-2022
- FDA event ID
- 90859
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Lisinopril
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Sep 2022
- FDA classified
- 15 Sep 2022
- Reported
- 21 Sep 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Blood Pressure Medication
Timeline
| 13 Sep 2022 | Recall initiated by company | |
| 15 Sep 2022 | Classified by FDA | +2 days |
| 21 Sep 2022 | Published in enforcement report | +6 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: Foreign material (metal piece) embedded 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, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03
Where it was distributed
Product was distributed to major distributors/wholesalers nationwide.
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Which lots are affected?
Lot # Q201182, exp. date March 2024
Where was it sold?
Product was distributed to major distributors/wholesalers 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.
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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 Pharmaceuticals | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Lisinopril Tablets, USP, 5 mg recalled by Lupin PharmaceuticalsLisinopril | Lupin Pharmaceuticals | Other | Nationwide |