The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0706-2017·Announced 2017-05-31

Mylan Recalls Alprazolam Extended-Release Tablets for Dissolution Failures

Mylan Pharmaceuticals is recalling specific lots of Alprazolam Extended-Release Tablets because they failed to meet dissolution specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries. The hazard is a quality control failure (dissolution) without reported adverse health consequences, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottles (NDC 0378-5022-91). The recall affects 24,176 bottles, containing a total of 1,450,560 tablets. The specific lot number is 3065878, with an expiration date of 04/17. The product was distributed nationwide.

The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the drug releases into the body as intended. When a medication fails these specifications, it may not provide the expected therapeutic effect or could release the drug at an unintended rate.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a replacement or refund. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
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
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

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