The Recall Desk
LowFDA (Drugs)·D-0379-2022·Announced 2022-01-26

Rugby Antihistamine and Decongestant Tablets Recalled for Failed Dissolution

Dr. Reddy's Laboratories is recalling Rugby brand antihistamine and nasal decongestant tablets nationwide due to failed dissolution specifications. The affected product is NDC 0536-1242-07, Lot #AC2106452F with expiration date 3/31/2023.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall with no reported illnesses, injuries, or deaths. The hazard is a manufacturing specification failure (dissolution) that does not present an immediate, direct risk of harm. Class III recalls are typically scored as 1 or 2, and without evidence of actual adverse events, this falls into the Low category.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Rugby Antihistamine and Nasal Decongestant Extended-Release Tablets (Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg) due to failed dissolution specifications. The affected product is packaged in boxes of 30 tablets with NDC 0536-1242-07.

Lot #AC2106452F (expiration date 3/31/2023) has been identified as failing to meet dissolution specifications. A total of 2,352 boxes were distributed nationwide in the USA by Rugby Laboratories, located in Livonia, Michigan. The product was manufactured in India.

Consumers in possession of this medication should stop use immediately and consult with their pharmacist or physician regarding this recall. The product should not be used until further guidance is provided by the manufacturer or FDA.

The recalled product

Product
Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India.
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Antihistamine and Decongestant
Hazard
Affected units
2,352

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 #: AC2106452F
  • Exp. 3/31/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · dissolution failure

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