Food, drugs, devices › Aurobindo Pharma USA Inc.

Drug recall: Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc

FDA enforcement event 90949 · Class II · initiated 5 Oct 2022 · status Completed

DrugVoluntary: Firm initiated1 product recordEast Windsor, NJ

Aurobindo Pharma USA Inc. (East Windsor, NJ) initiated this drug recall on 5 Oct 2022; FDA lists 1 product record under event 90949, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.

Status: Completed. Initiation: voluntary: firm initiated. Aurobindo Pharma USA Inc. has 33 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Aurobindo Pharma USA Inc., East Windsor, NJ.

Reason for recall

"CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0021-2023	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	9504 bottles	Class II	Completed	2 Nov 2022

Context

65%of 2022 drug events are Class II325 events that year

1product record in this eventfirm median: 1

33events on this register for the firm

Other enforcement events for Aurobindo Pharma USA Inc.

Initiated	Product (first record)	Type	Class	Records
23 Jul 2026	Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 P	Drug	Class II	1
22 May 2025	Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle,	Drug	Class II	1
6 Dec 2024	Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightst	Drug	Class II	1
7 Nov 2024	Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-	Drug	Class II	3
11 Jul 2024	Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distrib	Drug	Class I	1
24 Apr 2024	Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, ND	Drug	Class II	2
2 Aug 2023	Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-127	Drug	Class II	1
21 Jul 2023	Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 P	Drug	Class II	2
22 May 2023	Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walg	Drug	Class II	1
5 Apr 2022	Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for A	Drug	Class III	1

All 33 events for Aurobindo Pharma USA Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Completed. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.