The Recall Desk
ModerateFDA (Drugs)·D-0386-2022·Announced 2022-01-26

Leader 12HR Allergy & Congestion Relief tablets fail dissolution test

Dr. Reddy's Laboratories is recalling Leader brand 12HR Allergy & Congestion Relief tablets due to failed dissolution specifications. The product may not release its active ingredients properly.

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 with no reported illnesses or injuries. The hazard—failed dissolution—is a quality/efficacy issue rather than a safety issue causing direct harm. Class III recalls are typically scored 1 or 2; this scores 2 because it involves active pharmaceutical ingredients whose improper release could theoretically affect therapeutic efficacy.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Leader 12HR Allergy & Congestion Relief tablets (containing Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg) distributed nationwide in the USA. The recall affects approximately 10,536 boxes.

The product is being recalled because it failed to meet dissolution specifications. This means the tablets may not properly dissolve and release their active ingredients as intended, potentially reducing their effectiveness.

Affected lots include: 79C002625B (expiration 4/30/2022), AC2103328G (expiration 1/31/2023), and AC2106452C (expiration 3/31/2023). The product was manufactured by Dr. Reddy's Laboratories, Inc. and distributed by Cardinal Health, Dublin, Ohio.

Consumers who have purchased this product should stop using it and contact their pharmacy or healthcare provider with questions. The product is identified by NDC 70000-0518-1 (20 extended-release tablets per box).

The recalled product

Product
Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India.
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Antihistamine / Decongestant
Hazard
  • dissolution-failure
  • efficacy-issue

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 (6)

  • Lot #s: 79C002625B
  • Exp. 4/30/2022
  • AC2103328G
  • Exp. 1/31/2023
  • AC2106452C
  • Exp. 3/31/2023.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category