FDA Drug recall D-0655-2026
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02)
- FDA Drug
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02) by Lupin Pharmaceuticals, citing presence of Foreign Substance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0655-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-06-04 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
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
Presence of Foreign Substance
Identifiers
| ndc | 70748-332-03 |
|---|---|
| ndc | 70748-332-02 |
| ndc | 70748-332-04 |
| code_info | Lots: a) HA00937, HA00939, HA00941, HA00971, H00973, HA00975, Expires: 7/31/2026; HA00987, HA00989, HA00991, HA01010,…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, HA01267, HA01278, HA01280, HA01282, HA01284, HA01288, HA01290, HA01292, HA01298, Expires: 11/30/2026; HB00002, HB00004, HB00006, HB00017, HB00019, HB00021, HB00023, HB00025, HB00031, HB00033, HB00035, HB00037, HB00039, HB00041, HB00043, Expires: 12/31/2026; HB00049, HB00051, HB00076, HB00078, HB00080, HB00082, HB00084, Expires: 1/31/2027; HB00128, HB00130, HB00132, HB00134, HB00157, HB00159, HB00161, HB00196, HB00198, HB00200, Expires: 2/28/2027; HB00224, HB00226, HB00228, HB00230, HB00240, HB00242, Expires: 3/31/2027; HB00416, HB00417, HB0041 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0655-2026%22
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