CVS Allergy & Congestion Relief Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling CVS Allergy & Congestion Relief tablets (fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg extended-release) nationwide due to failed dissolution specifications.
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 defect (failed dissolution specifications) that is theoretical in nature with no documented harm to consumers.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Allergy & Congestion Relief Allergy Relief D extended-release tablets distributed by CVS Pharmacy, Inc. The product contains fexofenadine HCl 60 mg and pseudoephedrine HCl 120 mg per tablet. Lot #AC2103329I with expiration date 1/2023 is affected. Approximately 14,976 cartons were distributed nationwide.
The recall was initiated because the tablets failed to meet dissolution specifications. This means the tablets may not dissolve properly in the body, potentially affecting the delivery and effectiveness of the medication.
Consumers who have purchased this product should stop using it and contact their healthcare provider if they have any questions or concerns about their use of this medication.
The recalled product
- Product
- Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in India, NDC 69842-249-20
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Affected units
- 14,976
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 #: AC2103329I
- Exp 1/2023
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.
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