The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0385-2022·Announced 2022-01-26

CVS Health Allergy Relief D Tablets Recalled for Failed Dissolution

CVS Health Allergy Relief D Extended Release Tablets are being recalled because they failed to meet dissolution specifications. The recall affects 41,784 boxes distributed nationwide.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. Failed dissolution specifications constitute a labeling/manufacturing defect with potential efficacy concerns but no documented harm, meeting the criteria for Moderate severity.

Plain-English summary

CVS Health Allergy Relief D, containing Fexofenadine HCl 60mg (antihistamine) and Pseudoephedrine HCl 120mg (nasal decongestant), is being recalled due to failed dissolution specifications. The product is supplied in two configurations: 20-count boxes (UPC 050428436189) and 30-count boxes (UPC 050428290538).

The recall affects approximately 41,784 boxes that were distributed nationwide in the USA. The affected lot numbers are: for 20-count boxes, AC2000968A and AC2000968F (expiration 8/31/2022); for 30-count boxes, 79C002624B (expiration 4/30/2022), AC2103330G, and AC2103330H (expiration 1/31/2023). The product was manufactured by Dr. Reddy's Laboratories, Inc. in India and distributed by CVS Pharmacy Inc.

Consumers who have purchased this product should stop using it. Those with questions or concerns should contact their healthcare provider or pharmacist.

The recalled product

Product
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive…
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Antihistamine / Decongestant
Hazard
Affected units
41,784

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 (7)

  • Lot #s: a) (20-count): AC2000968A
  • AC2000968F
  • Exp. 8/31/2022. b) (30-count): 79C002624B
  • Exp. 4/30/2022
  • AC2103330G
  • AC2103330H
  • Exp. 1/31/2023.

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 →

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

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