amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Te
Summary
The FDA issued a recall for amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distrib by Aurobindo Pharma USA Inc. Reason: Discoloration: consumer complaints received for discolored tablets.
Details
Source
Drug Recall
External ID
9a86076c-d9b0-4978-bbd7-e48cc989d47b
Action Date
2026-10-07
Status
Ongoing
Category
drug
Product Description
amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count bottle, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, Made in India, NDC 72288-692-01. UPC 1 95515 04888 0
Lot/Code Info: Lot# ACD124048A, Exp Date: 11/30/2027.
Quantity Affected: 7,836 1000-count bottles
Reason for Recall
Discoloration: consumer complaints received for discolored tablets
Distribution
US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-18
Company
East Windsor, NJ
Context & Analysis
This is a unclassified recall.
This was one of 23 drug recalls issued in the same week, part of 40 drug-related FDA actions this month.
Aurobindo Pharma USA Inc has 19 FDA actions in our database, including 19 recalls.
Frequently Asked Questions
What is a FDA recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aurobindo Pharma USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aurobindo Pharma USA Inc have FDA actions?
Aurobindo Pharma USA Inc has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "9a86076c-d9b0-4978-bbd7-e48cc989d47b" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for drugRelated Actions
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef
ProRx LLC · 2025-11-05
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Perrigo Company PLC · 2022-03-02
Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 8826
Little Moon Essentials LLC · 2024-07-10
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
CARDINAL HEALTHCARE · 2024-01-03
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 6
Sentara Infusion Services · 2023-02-22