Mylan Alprazolam ER Recall: Failed Dissolution Specs
Mylan recalls 1 mg Alprazolam Extended-release tablets due to failed dissolution specifications. Check your lot number and expiration date for details.
Use caution until it’s fixed
Failed Dissolution Specifications
Contact the company
What happened, in plain English
Mylan Pharmaceuticals Inc. is recalling a specific batch of Alprazolam Extended-release Tablets, USP, 1 mg, in 60-count bottles. The recall is necessary because the product failed dissolution specifications, which may affect how the medication releases into the body. This particular issue involves NDC 0378-5022-91. Read more at govinfonow.com/recall/42578-mylan-alprazolam-er-recall-failed-dissolution-specs.
Source Summary by GovInfoNow · govinfonow.com/recall/42578-mylan-alprazolam-er-recall-failed-dissolution-specs · Updated October 9, 2026 · FDA enforcement record: FDA #D-0706-2017
Cite this page
“Mylan Alprazolam ER Recall: Failed Dissolution Specs.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42578-mylan-alprazolam-er-recall-failed-dissolution-specs. Based on FDA recall #D-0706-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0706-2017%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning the drug may not release from the extended-release formulation as intended. This could result in the medication not working effectively or releasing too quickly, potentially altering its therapeutic effect or safety profile for the user.
Who’s affected
Individuals who have been prescribed Alprazolam Extended-release Tablets, USP, 1 mg by Mylan Pharmaceuticals Inc. are affected. Those who purchased the specific lot and expiration date listed in the record are at risk of receiving a product that does not meet dissolution standards.
How to tell if you have this one
Check your bottle for NDC 0378-5022-91 and Code 0378-5022-91. Verify that the lot number is 3065878 and the expiration date is 04/17. The product is a 60-count bottle of Rx Only Alprazolam Extended-release Tablets, USP, 1 mg.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches NDC 0378-5022-91, Lot 3065878, and Exp. 04/17.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine the next steps for your prescription.
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 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.
Similar recalls
Other Mylan recalls
Latest drug recalls
Keep exploring
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-0706-2017 (June 22, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0706-2017 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.