CVS Allergy Relief D Extended-Release Tablets Recall
CVS Allergy Relief D extended-release tablets (Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg) are being recalled because they failed dissolution specifications, meaning the tablets may not release the medication properly.
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 involving a dissolution specification failure with no reported illnesses or injuries. The hazard is technical/manufacturing-related rather than related to a known harmful substance, and no patient harm has been reported.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Allergy Relief D Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg extended-release tablets distributed by CVS Pharmacy. The 30-tablet packages are made in India with NDC 69842-249-30 and lot number AC2103329C, expiration date 1/2023.
The recall was initiated because the product failed dissolution specifications. This means the tablets may not dissolve and release the active ingredients at the proper rate, potentially affecting the medication's effectiveness.
The product was distributed nationwide across the United States. Consumers who have purchased this product should stop using it and consult with their pharmacist or healthcare provider about proper disposal and alternative allergy relief options.
The recalled product
- Product
- Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
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 #: AC2103329C
- 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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