The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0270-2022·Announced 2021-12-15

Fexofenadine and Pseudoephedrine Tablets Recalled for Failed Dissolution

Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended Release Tablets because they failed dissolution specifications, which may affect how the medication works in the body.

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 an FDA Class III recall for a pharmaceutical product. The hazard is a manufacturing defect (failed dissolution specifications) with no reported illnesses or injuries, making it a typical Class III case that falls in the Moderate category per the rubric.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Antihistamine & Nasal Decongestant tablets containing Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release, 12 Hour formulation, distributed under the brand Rugby Laboratories. The recall affects 2352 cartons with lot number AC2103329H and expiration date 1/2023.

The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution specifications ensure that a tablet breaks down and releases its active ingredients at the proper rate in the body. When a tablet fails these specifications, the medication may not work as intended, potentially leaving consumers without expected allergy and congestion relief.

The affected product was distributed nationwide in the United States. Consumers who have this medication should stop using it and contact their healthcare provider or pharmacist for advice on how to proceed. The product can be returned to the point of purchase.

The recalled product

Product
Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 20 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152…
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Antihistamine / Decongestant
Hazard
Affected units
2,352

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 #: AC2103329H
  • 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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