The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0384-2022·Announced 2022-01-26

QC Quality Choice Fexofenadine/Pseudoephedrine Tablets Recalled for Failed Dissolution

Dr. Reddy's Laboratories is recalling QC Quality Choice Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg Extended-Release Tablets nationwide due to failed dissolution specifications that may reduce the medication's effectiveness.

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 a USDA/FDA Class III recall with no reported illnesses or injuries. The hazard is a manufacturing defect (failed dissolution) that could reduce drug effectiveness, which is a quality issue rather than a direct safety threat. This fits the "low-risk" or precautionary recall profile, and Class III recalls are typically scored 1–2.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling QC Quality Choice Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg Extended-Release Tablets, USP (Allergy & Congestion) distributed by C.D.M.A., Inc. The recall affects 9,984 boxes with NDC 63868-729-10, distributed nationwide in the USA.

The recall is due to failed dissolution specifications. Dissolution testing is a quality control measure that ensures tablets break down and release their active ingredients at the expected rate. When tablets fail dissolution specifications, the medication may not become available for absorption in the body as intended, potentially reducing its effectiveness in treating allergy and congestion symptoms.

The affected product has lot numbers 79C002624D and 79C002625C, with an expiration date of 4/30/2022. The tablets were manufactured in India.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product should not be discarded in household trash or flushed down drains; consumers should ask a pharmacist about proper disposal.

The recalled product

Product
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Over-the-Counter Allergy and Decongestant
Hazard
Affected units
9,984

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 (3)

  • Lot #s: 79C002624D
  • 79C002625C
  • Exp. 4/30/2022.

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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