Food, drugs, devices › Aurobindo Pharma USA Inc.

Drug recall: Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton

FDA enforcement event 85852 · Class II · initiated 12 Jun 2020 · status Terminated · terminated 21 Dec 2022

DrugVoluntary: Firm initiated1 product recordEast Windsor, NJ

FDA enforcement event 85852 is a drug recall by Aurobindo Pharma USA Inc. of East Windsor, NJ, initiated 12 Jun 2020 and classified Class II, with 1 product record.

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. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 21 Dec 2022. 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

"Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg."

Distribution

"U.S.A. Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1370-2020	Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-846-05	1440 bottles	Class II	Terminated	1 Jul 2020

Context

64%of 2020 drug events are Class II342 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 Oct 2022	Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc	Drug	Class II	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: "Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg."

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: "U.S.A. Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 21 Dec 2022. "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.