The Recall Desk
SevereFDA (Drugs)·D-0606-2017·Announced 2017-03-29

Legacy Pharmaceutical Recalls Atenolol Tablets Due to Foreign Tablet Presence

Legacy Pharmaceutical Packaging LLC is recalling 48,012 bottles of atenolol 50 mg tablets because a customer reported finding a paroxetine 20 mg tablet inside a bottle.

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, which corresponds to a Severe severity score according to the rubric, particularly given the risk of administering the wrong medication.

Plain-English summary

Legacy Pharmaceutical Packaging LLC is recalling 48,012 bottles of atenolol 50 mg tablets, USP, 30-count, Rx only. The recall was initiated after a customer complaint reported that a bottle of atenolol 50 mg tablets contained a paroxetine 20 mg tablet.

The affected product is identified by Lot # 161901 and an expiration date of 04/18. The product was distributed by The Kroger Co. and manufactured for Zydus Pharmaceuticals USA Inc. It was shipped to distribution centers in Tennessee, Indiana, and Arizona, and then further shipped to retail pharmacies nationwide in the USA.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to return the product or obtain a replacement. The recall is classified as FDA Class II.

The recalled product

Product
ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH 45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68
Affected units
48,012

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)

  • Lot # 161901
  • Exp 04/18

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically: