CLASS II Drug recall · Reported 5 Aug 2020 · 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 17 Jul 2020 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-1413-2020
- FDA event ID
- 86053
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Lisinopril
- Manufacturer
- BluePoint Laboratories
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jul 2020
- FDA classified
- 28 Jul 2020
- Reported
- 5 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 17 Jul 2020 | Recall initiated by company | |
| 28 Jul 2020 | Classified by FDA | +11 days |
| 5 Aug 2020 | Published in enforcement report | +8 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 Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Product as listed by the FDA
Lisinopril Tablets USP, 10 mg, 1000 count bottles, Manufactured by: Lupin Limited, Nagpur INDIA, For BluePoint Laboratories NDC 68001-334-08
Where it was distributed
Product was distributed to OH and may have been further distributed throughout the United States.
Questions about this recall
Is Lisinopril Tablets USP, 10 mg recalled?
Yes. Lupin Pharmaceuticals recalled Lisinopril Tablets USP, 10 mg on 17 Jul 2020. The recall is Class II and its status is Terminated. Recall number D-1413-2020.
Why was it recalled?
Presence of Foreign Tablets/Capsules: Lisinopril Tablets USP, 20mg found in a 1000 count bottle of Lisinopril Tablets USP, 10mg
Which lots are affected?
Lot # Q000232, exp. date 01/2022
Where was it sold?
Product was distributed to OH and may have been further distributed 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, 5 mg recalled by Lupin PharmaceuticalsLisinopril | Lupin Pharmaceuticals | Other | Nationwide |