CLASS II Drug recall · Reported 10 May 2017 · FDA Enforcement Report
Fluconazole Tablets, USP, 100 mg Unit Dose recalled
The Harvard Drug Group is recalling Fluconazole Tablets, USP, 100 mg Unit Dose, distributed nationwide in the US. The recall was initiated on 5 Jan 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0688-2017
- FDA event ID
- 77106
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Brand
- Fluconazole
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jan 2017
- FDA classified
- 28 Apr 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 5 Jan 2017 | Recall initiated by company | |
| 28 Apr 2017 | Classified by FDA | +113 days |
| 10 May 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the US
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot#: T-00520, EXP 02-17, T-00632, T-00699, EXP. 04-17
Where was it sold?
Nationwide within the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 77106This product is part of a recall event; the main page for the event is Fluconazole Tablets, USP, 200 mg Unit Dose recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fluconazole Tablets, USP, 200 mg Unit Dose recalledFluconazole | The Harvard Drug Group | Potency & Assay | Nationwide |
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Fluconazole recalls
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride recalled | Renaissance Lakewood | Packaging Defects | Nationwide |
| Drug | CLASS III | Fluconazole Injection, USP, 2 mg/mL, a) recalled by Renaissance Lakewood | Renaissance Lakewood | Potency & Assay | Nationwide |