The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1499-2022·Announced 2022-09-14

Difluprednate Eye Drops Recalled for Defective Container Sterility Risk

Cipla is recalling 117,844 bottles of Difluprednate eye drops nationwide due to defective containers where the protective cap can break, potentially exposing the dropper tip and compromising sterility.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a defective ophthalmic container that could compromise product sterility, qualifying as a risk-of-harm product. No illnesses, injuries, or hospitalizations have been reported, making the hazard theoretical rather than established.

Plain-English summary

Cipla USA, Inc. is recalling Difluprednate Ophthalmic Emulsion 0.05% in 5 mL bottles. Approximately 117,844 bottles have been distributed nationwide in the United States.

The recall was initiated because of a defective container where the protective cap can break, exposing the dropper tip. This exposure could compromise the sterility of the product.

Consumers who have received the affected product should stop using it and consult their healthcare provider for a replacement. The affected lot numbers are: DEG1HC2, DEG2HC2, DEG3HC2, DEG4HC2, DEG5HC2, DEG6HC2 (expiration 01/2023), DEG1IC2, DEG2IC2, DEG3IC2, DEG4IC2 (expiration 02/2023), DEG1LC2, DEG2LC2 (expiration 05/2023), and DEG1BD2, DEG2BD2, DEG3BD2 (expiration 07/2023).

The recalled product

Product
DIFLUPREDNATE (DIFLUPREDNATE)
Brand
DIFLUPREDNATE
Manufacturer
CIPLA
Category
Drug — Ophthalmic
Hazard
Affected units
117,844

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • Lot #: DEG1HC2
  • DEG2HC2
  • DEG3HC2
  • DEG4HC2
  • DEG5HC2
  • DEG6HC2
  • Exp 01/2023
  • DEG1IC2
  • DEG2IC2
  • DEG3IC2
  • DEG4IC2
  • Exp 02/2023
  • DEG1LC2
  • DEG2LC2
  • Exp 05/2023
  • DEG1BD2
  • DEG2BD2
  • DEG3BD2
  • Exp 07/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by CIPLA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · DIFLUPREDNATE

Same manufacturer · CIPLA

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Same hazard · sterility compromise

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