The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0688-2017·Announced 2017-05-10

Harvard Drug Group Recalls Fluconazole Tablets for Failed Dissolution

The Harvard Drug Group is recalling 2,341 cartons of Fluconazole 100 mg tablets because they failed to meet dissolution specifications.

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 typically involves a temporary or medically reversible adverse health consequence. The specific defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or mislabeling of a common allergen.

Plain-English summary

The Harvard Drug Group is voluntarily recalling 2,341 cartons of Fluconazole Tablets, USP, 100 mg. The product is distributed nationwide in the United States. The recall was initiated because the tablets failed to meet required dissolution specifications.

The affected product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Limited in India and distributed by Major Pharmaceuticals. The specific lots involved are T-00520, T-00632, and T-00699, with expiration dates of 02-17 and 04-17. The National Drug Codes (NDC) for the affected packaging are 0904-6500-61 and 0904-6501-61.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this specific medication.

The recalled product

Product
FLUCONAZOLE (FLUCONAZOLE)
Brand
FLUCONAZOLE
Manufacturer
The Harvard Drug Group
Category
Drug — Antifungal
Hazard
Affected units
2,341

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 (5)

  • Lot#: T-00520
  • EXP 02-17
  • T-00632
  • T-00699
  • EXP. 04-17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by The Harvard Drug Group 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 · FLUCONAZOLE

Same manufacturer · The Harvard Drug Group

See all →

Same hazard · failed dissolution

See all →

Similar recalls