Mylan Pharmaceuticals Alprazolam Extended-release Tablets Recall

Why it was recalled

Failed Dissolution Specifications

Product description

Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91

Lot numbers, UPCs & expiration codes

Code: 0378-5022-91 Lot: 3065878; Exp. 04/17

Where it was sold

Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0706-2017
Classification: Class II
Status: Terminated
Recall initiated: Jun 22, 2016
FDA report date: May 31, 2017
Quantity: 24,176 bottles (1,450,560 tablets)
Recall type: Voluntary: Firm initiated
Recalling firm: Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0706-2017, exactly as published.

Show all FDA fields

City: Morgantown
State: WV
Status: Terminated
Country: United States
Event ID: 76922
Address: 781 Chestnut Ridge Rd
Code information: Code: 0378-5022-91 Lot: 3065878; Exp. 04/17
Postal code: 26505-2730
Report date: May 31, 2017
Product type: Drugs
Recall number: D-0706-2017
Classification: Class II
Recalling firm: Mylan Pharmaceuticals Inc.
Product quantity: 24,176 bottles (1,450,560 tablets)
Termination date: Jul 12, 2017
Reason for recall: Failed Dissolution Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
Distribution pattern: Nationwide
Recall initiation date: Jun 22, 2016
Initial firm notification: E-Mail
Center classification date: May 24, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0706-2017, published May 31, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.