Difluprednate Ophthalmic Emulsion — Class II drug recall D-1499-2022
Terminated recall by CIPLA, reported 2022-09-14, distributed nationwide. Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective ca
| Recall number | D-1499-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CIPLA, Warren, NJ, United States |
| Recall initiated | 2022-08-22 |
| Classified | 2022-09-07 |
| Reported by FDA | 2022-09-14 |
| Terminated | 2023-11-27 |
| Distributed | Nationwide (US) |
| Quantity | 117,844 bottles |
| Reason classes | sterility, packaging, device malfunction |
| NDC | 69097-0341, 69097-0341-35 |
| Lot numbers | DEG1BD2, DEG1HC2, DEG1IC2, DEG1LC2, DEG2BD2, DEG2HC2, DEG2IC2, DEG2LC2, DEG3BD2, DEG3HC2, DEG3IC2, DEG4HC2, DEG4IC2, DEG5HC2, DEG6HC2 |
| Expiration dates | 2023-01, 2023-02, 2023-05, 2023-07 |
Product
Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Reason for recall
Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
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-1499-2022. 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.