CLASS II Drug recall · Reported 8 Feb 2017 · FDA Enforcement Report
Flucanozole Tablets, USP, 200 mg, a) recalled
Dr. Reddy's Laboratories is recalling Flucanozole Tablets, USP, 200 mg, a) (, distributed nationwide in the US. The recall was initiated on 28 Dec 2016 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-0452-2017
- FDA event ID
- 76122
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Brand
- Fluconazole
- Manufacturer
- Dr. Reddy's Laboratories Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Dec 2016
- FDA classified
- 30 Jan 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 28 Dec 2016 | Recall initiated by company | |
| 30 Jan 2017 | Classified by FDA | +33 days |
| 8 Feb 2017 | Published in enforcement report | +9 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; 18 month stability time point
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
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications; 18 month stability time point
Which lots are affected?
a) 30 count C500228, exp 12/2016, C500848 and C500850, exp 01/2017 C503651 and C503653, exp 04/2017, b) 100 count C500226, exp 12/2016, C500848, C500850, exp 01/2017, C503649 and C503653, exp 04/2017
Where was it sold?
Nationwide
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
3 other products · FDA event 76122This product is part of a recall event; the main page for the event is Flucanozole Tablets, USP, 150 mg, Blister cards recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Flucanozole Tablets, USP, 150 mg, Blister cards recalledFluconazole | Dr. Reddy's Laboratories | Potency & Assay | Nationwide | |
| CLASS II | Flucanozole Tablets, USP, 50 mg, a) recalled by Dr. Reddy's LaboratoriesFluconazole | Dr. Reddy's Laboratories | Potency & Assay | Nationwide | |
| CLASS II | Flucanozole Tablets, USP, 100 mg, a) recalledFluconazole | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
More recalls from Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | 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 |