Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg recall
FDA recall D-0532-2025 · initiated Jun 20, 2025
Lupin Pharmaceuticals Inc. recalled Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg in Jun 2025 — an FDA Class II recall (D-0532-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was 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.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 58,968 bottles
Details
- Product
- 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
- Recalling company
- Lupin Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed nationwide within the United States.
- Initiated
- Jun 20, 2025
- FDA report date
- Jul 23, 2025
Frequently asked
- Was Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg recalled?
- Lupin Pharmaceuticals Inc. recalled Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg in Jun 2025 — an FDA Class II recall (D-0532-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg recalled?
- Per the FDA enforcement record, the reason for recall D-0532-2025 was: 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.
- Is a recalled Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg are affected?
- Distributed: Product was distributed nationwide within the United States.. The recall covers these lots — Lot #: QA01081, Exp. Date April 2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0532-2025.