Aurobindo Pharma USA Inc: Amazon, Acetaminophen, Extra Strength, 500mg Caplets, 1000-count Bottle
Recall Summary Sun Pharmaceutical is recalling Xyvona (levorphanol tartrate) 3mg tablets nationwide because the FDA denied approval to market the product under the brand name Xyvona. The affected product is a prescription pain medication distributed under NDC 72245-058-10 that was manufactured by Ohm Laboratories and distributed by Fort Bio-Pharma. This recall impacts all U.S. states and the District of Columbia.
- Recalling firm
- Aurobindo Pharma USA Inc
- Product
- 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
- Reason
- Discoloration: consumer complaints received for discolored tablets
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-18
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/79766ba7-f2c0-40e8-8458-c4866c5ada69