CLASS II Drug recall · Reported 28 Dec 2022 · FDA Enforcement Report
Quinapril Tablets USP, 20 mg recalled by Lupin Pharmaceuticals
Lupin Pharmaceuticals is recalling Quinapril Tablets USP, 20 mg, distributed nationwide in the US. The recall was initiated on 7 Dec 2022 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-0089-2023
- FDA event ID
- 91279
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Brand
- Quinapril
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Dec 2022
- FDA classified
- 23 Dec 2022
- Reported
- 28 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 7 Dec 2022 | Recall initiated by company | |
| 23 Dec 2022 | Classified by FDA | +16 days |
| 28 Dec 2022 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09
Where it was distributed
Product was distributed by major distribution chains nationwide.
Questions about this recall
Why was it recalled?
CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Which lots are affected?
Lot #: G102929, Exp 04/2023
Where was it sold?
Product was distributed by major distribution chains nationwide.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 91279| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Quinapril Tablets USP, 40 mg recalled by Lupin PharmaceuticalsQuinapril | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |
More recalls from Lupin Pharmaceuticals
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
Other Quinapril recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Quinapril Tablets USP, 40 mg recalled by Lupin PharmaceuticalsQuinapril | Lupin Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg recalledQuinapril Hydrochloride/hydrochlorothiazide | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | quinapril HCl/hydrochlorothiazide tablets, 20 mg/25 mg* recalled | Pfizer | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | quinapril HCl/hydrochlorothiazide tablets, 20 mg/12.5 mg* recalled | Pfizer | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | quinapril and hydrochlorothiazide tablets, 20 mg/25 mg* recalled | Pfizer | Nitrosamine Impurity | Nationwide |