Harvard Drug Group Recalls Fluconazole Tablets Due to Dissolution Failure
The Harvard Drug Group is recalling Fluconazole Tablets, USP 200 mg due to failed dissolution specifications. Check your lot number and expiration date.
Use caution until it’s fixed
Failed Dissolution Specifications
Contact the company
What happened, in plain English
The Harvard Drug Group has recalled one lot of Fluconazole Tablets, USP, 200 mg because the medication did not meet dissolution specifications. This means the tablets may not release the drug properly in the body, potentially reducing its effectiveness. The recall affects 914 cartons distributed nationwide. Read more at govinfonow.com/recall/42096-harvard-drug-group-recalls-fluconazole-tablets-due-to-dissolution-failure.
Source Summary by GovInfoNow · govinfonow.com/recall/42096-harvard-drug-group-recalls-fluconazole-tablets-due-to-dissolution-failure · Updated October 11, 2026 · FDA enforcement record: FDA #D-0689-2017
Cite this page
“Harvard Drug Group Recalls Fluconazole Tablets Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42096-harvard-drug-group-recalls-fluconazole-tablets-due-to-dissolution-failure. Based on FDA recall #D-0689-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0689-2017%22&limit=1).
Why it’s dangerous
The recalled tablets failed dissolution specifications, which is a quality control test ensuring the drug breaks down and releases its active ingredient as intended. If the tablets do not dissolve correctly, the patient may not absorb the full dose of the medication, leading to inadequate treatment of the infection.
Who’s affected
Patients who have been prescribed Fluconazole Tablets, USP, 200 mg and purchased them from pharmacies or healthcare providers across the United States are affected. Individuals relying on this specific lot for treatment may receive a less effective dose.
How to tell if you have this one
Check your medication for the following details: Brand 'The Harvard Drug Group', Product 'Fluconazole Tablets, USP, 200 mg', NDC '0904-6501-61', Lot number 'T-00519', and Expiration date '01-17'. The product is distributed in 100-count unit dose cartons.
- Brand
The Harvard Drug Group- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide within the US- NDC
0904-6500-06, 0904-6500-61, 0904-6501-06, 0904-6501-61
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0688-2017 | Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6500-61; Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17 | 2,341 cartons |
| D-0689-2017 | Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI 48150 USA, NDC 0904-6501-61; Lot #:T-00519, Exp. 01-17 | 914 cartons |
What to do — step by step
Check Your Medication
Verify if your Fluconazole Tablets match the recalled NDC, lot number T-00519, and expiration date 01-17.
Consult Your Pharmacist
Contact your pharmacist or healthcare provider to determine if you have the recalled product and to discuss alternative treatment options.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the US” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How many units of this product are being recalled?
A total of 914 cartons are included in this recall.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0689-2017 (January 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0689-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.