CLASS II ONGOING Drug recall · Reported 23 Jul 2025 · FDA Enforcement Report
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg recalled
Lupin Pharmaceuticals is recalling Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, distributed nationwide in the US. The recall was initiated on 20 Jun 2025 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-0532-2025
- FDA event ID
- 97118
- Recalling firm
- Lupin Pharmaceuticals, Naples, FL
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Jun 2025
- FDA classified
- 17 Jul 2025
- Reported
- 23 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 20 Jun 2025 | Recall initiated by company | |
| 17 Jul 2025 | Classified by FDA | +27 days |
| 23 Jul 2025 | 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
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
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 and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA, NDC 68180-519-01
Where it was distributed
Product was distributed nationwide within the United States.
Questions about this recall
Is Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg recalled?
Yes. Lupin Pharmaceuticals recalled Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg on 20 Jun 2025. The recall is Class II and its status is Ongoing. Recall number D-0532-2025.
Why was it recalled?
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Which lots are affected?
Lot #: QA01081, Exp. Date April 2027
Where was it sold?
Product was distributed nationwide within 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 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 |
| Drug | CLASS II | Lisinopril Tablets, USP, 5 mg recalled by Lupin PharmaceuticalsLisinopril | Lupin Pharmaceuticals | Other | Nationwide |