Food, drugs, devices › Aurobindo Pharma USA Inc.

Drug recall: Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Man

FDA enforcement event 85756 · Class III · initiated 26 May 2020 · status Terminated · terminated 10 Jan 2023

DrugVoluntary: Firm initiated2 product recordsEast Windsor, NJ

Aurobindo Pharma USA Inc. (East Windsor, NJ) initiated this drug recall on 26 May 2020; FDA lists 2 product records under event 85756, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 21% of the 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 10 Jan 2023. 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

"Failed Impurities/ Degradation Specifications"

Distribution

"U.S.A. Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1314-2020	Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-680-30	13322 bottles	Class III	Terminated	24 Jun 2020
D-1315-2020	Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA, Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810, NDC 66993-682-30	7547 bottles	Class III	Terminated	24 Jun 2020

Context

21%of 2020 drug events are Class III342 events that year

2product records 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: "Failed Impurities/ Degradation Specifications"

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 10 Jan 2023. "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.