Product Details
Product Description:
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
Reason for Recall:
Presence of Foreign Substance
Product Quantity:
2,530,182 bottles
Recall Number:
D-0655-2026
Code Information:
Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010, HA01012, HA01014, HA01016, HA01048, Expires: 8/31/2026; HA01120, HA01137, HA01129, HA01138, HA01133, Expires: 9/30/2026; HA01148, HA01196, HA01198, HA01200, HA01206, HA01208, HA01210, HA01212, HA01214, HA01216, HA01218, HA01220, Expires: 10/31/2026; HA01236, HA01238, HA01240, HA01244, HA01246, HA01248, HA01261, HA01263, HA01265, more...
Classification:
Class II
Event Details
Event ID:
99144
Voluntary / Mandated:
Voluntary: Firm initiated
Product Type:
Drugs
Initial Firm Notification of Consignee or Public:
Letter
Status:
Ongoing
Distribution Pattern:
U.S. Nationwide
Recalling Firm:
Lupin Pharmaceuticals Inc.
5801 Pelican Bay Blvd Ste 500
Naples, FL 34108-2734
United States
Press Release URL(s):
Press Release Not Issued For This Recall
Recall Initiation Date:
6/4/2026
Center Classification Date:
6/30/2026
Date Terminated:
N/A
Very strange that they haven’t reported the analysis of what the “foreign substance” is. Was it visible to naked eye? Was it a specific color? Chemical? Biological?
I would guess that some kind of analysis had to be done.