Aurobindo Rasagiline Tablets 0.5mg Recall: Failed Dissolution Specifications
Aurobindo Pharma recalls 0.5mg Rasagiline Tablets (30-count) due to failed dissolution testing. This may affect drug effectiveness. Check NDC 0378-1270-93 and lot 3112444.
Lower-risk recall
Failed dissolution specifications - results obtained were below spec average.
Contact the company
What happened, in plain English
Aurobindo Pharma is recalling 0.5mg Rasagiline Tablets (30-count) because they failed dissolution testing. This could mean the medication doesn't work as intended, so affected users should contact their doctor. Read more at govinfonow.com/recall/33230-aurobindo-rasagiline-tablets-0-5mg-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/33230-aurobindo-rasagiline-tablets-0-5mg-recall-failed-dissolution-specifications · Updated August 17, 2026 · FDA enforcement record: FDA #D-1171-2023
Cite this page
“Aurobindo Rasagiline Tablets 0.5mg Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33230-aurobindo-rasagiline-tablets-0-5mg-recall-failed-dissolution-specifications. Based on FDA recall #D-1171-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1171-2023%22&limit=1).
Why it’s dangerous
The tablets failed dissolution testing, meaning they don't dissolve properly in the body. This could lead to the medication not working as intended, but it does not cause immediate harm or injury.
Who’s affected
People with a prescription for Rasagiline Tablets 0.5mg, 30-count bottles from Mylan Pharmaceuticals. Those who have the specific NDC 0378-1270-93 lot 3112444 are most at risk.
How to tell if you have this one
Check for the NDC code 0378-1270-93 on the bottle label. The lot number 3112444 and expiration date 8/2023 are also specific to this recall.
- Brand
Aurobindo Pharma- Category
Drug
What to do — step by step
Contact Your Doctor
Talk to your healthcare provider about the recall and possible next steps for your medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “USA 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 13 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
Is this recall dangerous?
No, the recall is for potential reduced effectiveness, not immediate safety risks.
What should I do if I have the recalled product?
Contact your doctor for advice on whether to continue using the medication.
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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-1171-2023 (August 2, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1171-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.