The Recall Desk
SevereFDA (Drugs)·D-0007-2015·Announced 2014-10-15

Zydus Recalls Atenolol Tablets Due to Superpotent Drug Complaint

Zydus Pharmaceuticals is recalling 5,400 bottles of Atenolol 25 mg tablets nationwide after a pharmacist reported that several tablets appeared noticeably thicker.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential significant harm such as superpotent drug issues.

Plain-English summary

Zydus Pharmaceuticals USA Inc. is recalling 5,400 bottles of ZyGenerics ATENOLOL Tablets, USP 25 mg (1000 count). The affected product is identified by lot number MP2292 and expiration date 01/16. The tablets were manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, NJ.

The recall was initiated following a complaint from a pharmacist who stated that several tablets were noticeably thicker in appearance. This observation led to the classification of the issue as a "Superpotent Drug" complaint. The product is distributed nationwide.

Consumers and healthcare providers should stop using the affected tablets and contact their healthcare provider or pharmacist for guidance. The recall is classified as Class II by the FDA.

The recalled product

Product
ATENOLOL (ATENOLOL)
Brand
ATENOLOL
Affected units
5,400

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 (1)

  • MP2292 Exp. 01/16

Distribution

Distributed nationwide across the United States.