Dr. Reddy's Flucanozole Tablets Recall: Failed Dissolution Specifications
Dr. Reddy's recalls 150mg Flucanozole tablets due to failed dissolution specifications and stability issues. Affected products were manufactured in India with specific NDC codes and expiration dates.
Lower-risk recall
Failed Dissolution Specifications; 18 month stability time point
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What happened, in plain English
Dr. Reddy's is recalling 150mg Flucanozole tablets that failed dissolution tests and stability checks. This means the medication may not work properly or could degrade over time, potentially affecting treatment effectiveness. Read more at govinfonow.com/recall/42101-dr-reddy-s-flucanozole-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/42101-dr-reddy-s-flucanozole-tablets-recall-failed-dissolution-specifications · Updated October 8, 2026 · FDA enforcement record: FDA #D-0451-2017
Cite this page
“Dr. Reddy's Flucanozole Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42101-dr-reddy-s-flucanozole-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0451-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0451-2017%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they may not dissolve properly in the body. The product also did not meet stability requirements for 18 months, which could lead to reduced effectiveness or degradation over time.
Who’s affected
Prescription holders of the recalled Flucanozole tablets in India. Patients who have been prescribed this medication are most at risk if they use the affected products.
How to tell if you have this one
Check for the product name 'Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards' with NDC codes 55111-145-12, C500222, C500515, or C500517. Products were manufactured in India and expired by December 2016 or March 2017.
- Brand
Dr. Reddy's- Category
Drug
All 4 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- NDC
55111-143-30, 55111-143-01, 55111-143-05, 55111-143-79, 55111-143-78, 55111-144-30, 55111-144-01, 55111-144-05, 55111-144-79, 55111-144-78, 55111-145-71, 55111-145-12, 55111-146-30, 55111-146-01, 55111-146-05, 55111-146-79, 55111-146-78
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0449-2017 | Flucanozole Tablets, USP, 50 mg, a) 30 count (NDC 55111-143-30) and b) 100 count (NDC 55111-143-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India; a) 30 count C500221, exp 12/2016, C502342, exp 03/2017 b) 100 count C500221, exp 12/2016, C502342, exp 03/2017 | a) 2472 bottles, b) 780 bottles |
| D-0450-2017 | Flucanozole Tablets, USP, 100 mg, a) 30 count (NDC 55111-144-30) and b) 100 count (NDC 55111-144-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India; a) 30 count C500224, exp 12/2016, C500846, exp 01/2017 b) 100 count C500224, exp 12/2016, exp 12/2016, C501608, exp 02/2017 and C503655, exp 04/2017 | a) 42,984 and b) 7,764 bottles |
| D-0451-2017 | Flucanozole Tablets, USP, 150 mg, 12x1 Blister cards, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India --- NDC 55111-145-12; C500222, C500515, and C500517, exp 12/2016, C502343, exp 03/2017 | 59,440 blister cards |
| D-0452-2017 | 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; 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 | a) 38,832 and b) 5,064 bottles |
What to do — step by step
Check Product Details
Verify the NDC codes and expiration dates listed in the recall notice to confirm if your tablets are affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 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
Are there any safety risks from using the recalled tablets?
The recall is due to potential reduced effectiveness and stability issues, not immediate safety risks like injury or death.
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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-0451-2017 (December 28, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0451-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.