The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0452-2017·Announced 2017-02-08

Dr. Reddy's Recalls Flucanazole Tablets for Dissolution Failures

Dr. Reddy's Laboratories is recalling Flucanazole 200 mg tablets nationwide due to failed dissolution specifications and stability issues.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which involves a situation that may cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution/stability) rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Flucanazole Tablets, USP, 200 mg, in 30-count and 100-count bottles. The recall affects specific lots with expiration dates ranging from December 2016 to April 2017. The product is distributed nationwide.

The recall was initiated because the tablets failed to meet dissolution specifications and had issues with the 18-month stability time point. Dissolution is a critical quality attribute that ensures the drug releases properly in the body; failure to meet these standards can affect the drug's performance.

Patients and healthcare providers should stop using the affected lots and contact their pharmacist or healthcare provider for a replacement. The recall is voluntary and is being conducted by the manufacturer in coordination with the FDA.

The recalled product

Product
FLUCONAZOLE (FLUCONAZOLE)
Brand
FLUCONAZOLE
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Antifungal
Hazard

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 (10)

  • a) 30 count C500228
  • exp 12/2016
  • C500848 and C500850
  • exp 01/2017 C503651 and C503653
  • exp 04/2017
  • b) 100 count C500226
  • C500848
  • C500850
  • exp 01/2017
  • C503649 and C503653

UPCs (1)

  • 0355111145127

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Dr. Reddy's Laboratories, Inc. 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 4 products in this recall →

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