CLASS II Drug recall · Reported 29 Apr 2020 · FDA Enforcement Report
Lisinopril Tablets USP, 20 mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Lisinopril Tablets USP, 20 mg, distributed nationwide in the US. The recall was initiated on 20 Apr 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-1250-2020
- FDA event ID
- 85511
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2020
- FDA classified
- 21 Apr 2020
- Reported
- 29 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 20 Apr 2020 | Recall initiated by company | |
| 21 Apr 2020 | Classified by FDA | +1 day |
| 29 Apr 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
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
Where it was distributed
Product was distributed Nationwide in the United States.
Questions about this recall
Is Lisinopril Tablets USP, 20 mg recalled?
Yes. Lupin Pharmaceuticals recalled Lisinopril Tablets USP, 20 mg on 20 Apr 2020. The recall is Class II and its status is Terminated. Recall number D-1250-2020.
Why was it recalled?
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
Which lots are affected?
Lot # Q000255, Exp 01/2022
Where was it sold?
Product was distributed Nationwide in 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 |