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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Drug
- 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.
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