Dr. Reddy's Tacrolimus Capsules 0.5mg Recall: Foreign 1mg Capsules Found
Dr. Reddy's recalls 0.5mg Tacrolimus capsules due to foreign 1mg capsules in some bottles. This may cause incorrect dosing. Check your bottle's lot number and contact for details.
Lower-risk recall
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Contact the company
What happened, in plain English
Dr. Reddy's is recalling 0.5mg Tacrolimus capsules because some bottles contain foreign 1mg capsules. This could lead to incorrect dosing if taken without noticing. Read more at govinfonow.com/recall/33897-dr-reddy-s-tacrolimus-capsules-0-5mg-recall-foreign-1mg.
Source Summary by GovInfoNow · govinfonow.com/recall/33897-dr-reddy-s-tacrolimus-capsules-0-5mg-recall-foreign-1mg · Updated August 18, 2026 · FDA enforcement record: FDA #D-0330-2023
Cite this page
“Dr. Reddy's Tacrolimus Capsules 0.5mg Recall: Foreign 1mg Capsules Found.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33897-dr-reddy-s-tacrolimus-capsules-0-5mg-recall-foreign-1mg. Based on FDA recall #D-0330-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0330-2023%22&limit=1).
Why it’s dangerous
The recalled capsules may contain 1mg tablets mixed with the labeled 0.5mg capsules. If someone takes the foreign 1mg capsules instead of the 0.5mg ones, they could get an incorrect dose.
Who’s affected
People prescribed Tacrolimus capsules by a doctor who own the recalled 100-count bottles. Those taking the medication are most at risk if they accidentally take the foreign capsules.
How to tell if you have this one
Check the bottle for a lot number starting with C2106445. The product is labeled as Tacrolimus 0.5mg, 100-count, Rx Only, with NDC 55111-525-01.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Check Bottle Contents
Look for foreign 1mg capsules inside the 0.5mg labeled bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 21 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0330-2023 (February 8, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0330-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.