prednisoLONE Acetate Ophthalmic Suspension — Class II drug recall D-0655-2026
Ongoing recall by Lupin Pharmaceuticals Inc., reported 2026-07-08, distributed nationwide. Presence of Foreign Substance
| Recall number | D-0655-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Naples, FL, United States |
| Recall initiated | 2026-06-04 |
| Classified | 2026-06-30 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 2,530,182 bottles |
| NDC | 70748-0332, 70748-0332-02, 70748-0332-03, 70748-0332-04 |
| Expiration dates | 2026-07-31, 2026-08-31, 2026-09-30, 2026-10-31, 2026-11-30, 2026-12-31, 2027-01-31, 2027-02-28, 2027-03-31, 2027-05-31, 2027-06-30, 2027-10-31, 2027-11-30, 2027-12-31, 2028-01-31, 2028-02-29, 2028-03-31 |
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 for recall
Presence of Foreign Substance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0655-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.