The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0269-2022·Announced 2021-12-15

OTC Allergy and Congestion Tablets Recalled for Failed Dissolution

Dr. Reddy's Laboratories is recalling 5,016 cartons of Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg Extended Release Tablets nationwide due to failed dissolution specifications. Affected lot is AC2103329F with expiration 1/2023.

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 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 Class III recall for a pharmaceutical defect (failed dissolution). The source text does not report any illnesses, injuries, or adverse events. The recall is precautionary in nature, addressing a manufacturing specification failure rather than a documented safety hazard, meeting criteria for Moderate severity.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Fexofenadine HCl 60 mg / Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion because the product failed to meet dissolution specifications. A total of 5,016 cartons with lot number AC2103329F and expiration date 1/2023 (NDC 43598-823-14) have been distributed nationwide in the United States.

The tablets are taken orally as an over-the-counter medication. If the product does not dissolve properly, the active ingredients may not be released and absorbed as intended, which could affect the intended therapeutic effect.

Consumers who have this product should stop taking it and consult their healthcare provider or pharmacist. The product can be returned to the place of purchase or discarded according to local waste disposal guidelines.

The recalled product

Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Brand
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Over-the-Counter Allergy & Congestion
Hazard
Affected units
5,016

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 #: AC2103329F
  • 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.

See all 9 products in this recall →

Related recalls

Same brand · FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI

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

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