CLASS II Drug recall · Reported 17 Jun 2020 · FDA Enforcement Report
Lisinopril Tablets, USP, 5 mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Lisinopril Tablets, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 28 May 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-1290-2020
- FDA event ID
- 85770
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Lisinopril
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 May 2020
- FDA classified
- 8 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 28 May 2020 | Recall initiated by company | |
| 8 Jun 2020 | Classified by FDA | +11 days |
| 17 Jun 2020 | 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
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Product as listed by the FDA
Lisinopril Tablets, USP, 5 mg, Rx Only, 1000-count bottle, Manufactured for: Lupin Pharmaceuticals Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Nagpur - 441 108, India, NDC 68180-513-03.
Where it was distributed
Nationwide within the US.
Questions about this recall
Is Lisinopril Tablets, USP, 5 mg recalled?
Yes. Lupin Pharmaceuticals recalled Lisinopril Tablets, USP, 5 mg on 28 May 2020. The recall is Class II and its status is Terminated. Recall number D-1290-2020.
Why was it recalled?
Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle.
Which lots are affected?
Lot # Q900683, Exp. 10/31/2022
Where was it sold?
Nationwide within the US.
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 |