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.
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 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.
- Hazard
- failed-dissolution
- reduced-efficacy
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.
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