The Recall Desk
ModerateFDA (Drugs)·D-0267-2022·Announced 2021-12-15

Allergy and Congestion tablets recalled due to failed dissolution specifications

Dr. Reddy's Laboratories is recalling Allergy and Congestion (Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg) Extended-Release Tablets because they failed to meet dissolution specifications. Approximately 4,896 cartons distributed nationwide are affected.

What this means for you

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. The hazard is a manufacturing/specification defect (failed dissolution) rather than contamination or a high-risk condition. Per the rubric, Class III recalls are typically scored 1 or 2; the dissolution failure represents a quality control issue that warrants a Moderate rating.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Allergy and Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP (20 tablets per carton, NDC 11822-7388-5) because the product failed dissolution specifications. The affected product is Lot #AC2103329E with an expiration date of January 2023.

Approximately 4,896 cartons were distributed nationwide by Rite Aid. The tablets are an over-the-counter combination medication used to treat allergy and congestion symptoms.

Consumers who have this product should stop using it. If you have questions or concerns, contact Dr. Reddy's Laboratories or your healthcare provider.

The recalled product

Product
ALLERGY AND CONGESTION (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Brand
ALLERGY AND CONGESTION
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Over-the-Counter Combination Medication
Hazard
Affected units
4,896

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 #: AC2103329E
  • 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 manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · dissolution failure

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