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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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.
- 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.
See all →- ModerateVarenicline tablets recalled after an assay value fell below specification
FDA (Drugs) · 2025-12-17
- Moderate
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- SevereLevetiracetam Injection Label Mismatch Nationwide Recall
FDA (Drugs) · 2025-04-23
- ModerateFDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-12-18
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateAntihistamine and Decongestant Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2021-12-15
- ModerateFexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2021-12-15
- LowFexofenadine and Pseudoephedrine allergy relief tablets recalled for failed dissolution
FDA (Drugs) · 2021-12-15
- ModerateOTC Allergy and Congestion Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2021-12-15
- ModerateAllergy and Congestion tablets recalled due to failed dissolution specifications
FDA (Drugs) · 2021-12-15
- ModerateAllergy Relief D tablets recalled for failed dissolution specifications
FDA (Drugs) · 2022-12-07