Drug recall: Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by…

Class II FDA enforcement event 92380. Recall start date: 22 May 2023. Status in the FDA record: Completed.

Reason for recall, in the words of FDA

Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.

Class II, in the words of FDA

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

Aurobindo Pharma USA Inc. started this drug recall on 22 May 2023. The firm address in the FDA record is in East Windsor, NJ. FDA put the recall in Class II. FDA event 92380 has 1 product record. The first FDA enforcement report date is 31 May 2023. The record gives the status Completed.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.

Recalling firm

Aurobindo Pharma USA Inc., East Windsor, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 92380: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0765-2023	Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.	87,360 bottles	Class II	Completed	31 May 2023

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2023: 281
Share of these events in Class II: 59%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 33

Other events of the firm

Other FDA enforcement events of 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
5 Oct 2022	Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc	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

Aurobindo Pharma USA Inc.: all 33 events

Official channels

FDA enforcement report D-0765-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 92380. https://recallregister.com/fda/ii/92380/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.
What quantity of product is in FDA event 92380?: The FDA record gives this quantity: 87,360 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2023 have the same class?: 59% of the 281 drug events that started in 2023 are in Class II.