The Recall Desk
LowFDA (Drugs)·D-0272-2022·Announced 2021-12-15

Fexofenadine and Pseudoephedrine allergy relief tablets recalled for failed dissolution

Dr. Reddy's Laboratories is recalling a 12 HR Allergy & Congestion Relief product distributed nationwide because the tablets failed to meet dissolution specifications, which may affect drug effectiveness.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is theoretical—failed dissolution may affect drug efficacy but poses no direct safety threat. Per the rubric, Class III recalls are typically scored 1 or 2.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling 12 HR Allergy & Congestion Relief tablets containing Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg. The recall affects 2496 cartons distributed nationwide in the USA.

The recall was issued because the product failed dissolution specifications. Dissolution specifications ensure that a tablet properly breaks down in the digestive system so the active ingredients can be absorbed and provide the intended therapeutic effect.

The affected product has the National Drug Code (NDC) 70000-0518-1, Lot #AC2103329G with an expiration date of January 2023. The product was distributed by Cardinal Health, Dublin, Ohio and manufactured by Dr. Reddy's Laboratories, Inc. in India.

Consumers who have this product should consult their healthcare provider or pharmacist for advice. The FDA classifies this as a Class III recall.

The recalled product

Product
12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Ohio 43107, Made in India, NDC 70000-0518-1.
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Antihistamine / Nasal Decongestant
Hazard
Affected units
2,496

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 #: AC2103329G
  • 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 →

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

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