CLASS II Drug recall · Reported 2 Nov 2022 · FDA Enforcement Report
Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg recalled
Aurobindo Pharma USA is recalling Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, distributed nationwide in the US. The recall was initiated on 5 Oct 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-0021-2023
- FDA event ID
- 90949
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 5 Oct 2022
- FDA classified
- 26 Oct 2022
- Reported
- 2 Nov 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 5 Oct 2022 | Recall initiated by company | |
| 26 Oct 2022 | Classified by FDA | +21 days |
| 2 Nov 2022 | Published in enforcement report | +7 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 and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
Where it was distributed
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?
Lots QE2021005-A and QE2021010-A, exp 01/2023
Where was it sold?
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.
More recalls from Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | 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 Tablets USP, 20 mg recalled by Lupin PharmaceuticalsQuinapril | Lupin Pharmaceuticals | 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 |