US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 21, 2022 (4 years ago)

Accuretic

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: N-nitroso-quinapril and N-nitroso-hydrochlorothiazide impurity above the acceptable daily intake limit.

What was recalled

Accuretic (quinapril HCl/hydrochlorothiazide) tablets, 20 mg/12.5 mg*, 90 Tablets, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY. NY 10017, Made in Germany, NDC 0071-5212-23 .

Recalling firm
Pfizer Inc.
NDC code
0071-5212-23
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0761-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Hydrochlorothiazide recalls

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Class II · Moderate risk Ongoing

Bisoprolol Fumarate and Hydrochlorothiazide tablets

Reason cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Unichem Pharmaceuticals USA Inc. NDC 29300-187-01 D-0301-2026
Class III · Low risk Ongoing

Bisoprolol Fumarate and Hydrochlorothiazide Tablets

Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

Glenmark Pharmaceuticals Inc., USA D-0199-2026
Class II · Moderate risk Ongoing

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg

Reason 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.

Lupin Pharmaceuticals Inc. NDC 68180-519-01 D-0532-2025