The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0378-2022·Announced 2022-01-26

Wal-Fex D Allergy and Decongestant Tablets Recalled for Failed Dissolution

Dr. Reddy's Laboratories is recalling Wal-Fex D Extended Release Tablets nationwide due to failed dissolution specifications. The affected product combines fexofenadine (antihistamine) and pseudoephedrine (decongestant).

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 1/5 (Low).

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 a manufacturing specification failure (failed dissolution) rather than a direct safety threat. The source text does not indicate any known harm to consumers.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Wal-Fex D Extended Release Tablets containing fexofenadine HCl 60mg and pseudoephedrine HCl 120mg. The recall affects approximately 67,848 boxes distributed nationwide in the USA. The product is being recalled because it failed to meet dissolution specifications.

Affected products are distributed by Walgreen Co. under the following NDC numbers and lot codes: - 20-tablet boxes (NDC 0363-1606-20): Lot #s AC2000968D (Exp. 8/31/2022), AC2103330J (Exp. 1/31/2023), AC2106452A, and AC2106452H (Exp. 3/31/2023) - 30-tablet boxes (NDC 0363-1606-30): Lot #s 79C002624C (Exp. 4/30/2022), AC2103328B, AC2103328C, AC2103330A, and AC2103330B (Exp. 1/31/2023)

Consumers who have purchased this product should stop using it and consult their healthcare provider if they have questions about their treatment.

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.
Category
Drug — OTC Antihistamine/Decongestant
Hazard
Affected units
67,848

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 (13)

  • Lot #s: a) (20-count box): AC2000968D
  • Exp. 8/31/2022
  • AC2103330J
  • Exp. 1/31/2023
  • AC2106452A
  • AC2106452H
  • Exp. 3/31/2023. b) (30-count box): 79C002624C
  • Exp. 4/30/2022
  • AC2103328B
  • AC2103328C
  • AC2103330A
  • AC2103330B
  • Exp. 1/31/2023.

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 brand · FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI

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

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Same hazard · dissolution failure

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