The Recall Desk
ModerateFDA (Drugs)·D-0383-2022·Announced 2022-01-26

Equate Allergy Relief D Tablets Recalled for Failed Dissolution

Dr. Reddy's Laboratories is recalling Equate Allergy Relief D Extended-Release Tablets distributed by Walmart nationwide due to failed dissolution specifications. The recall affects 137,856 boxes across multiple lot numbers.

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 an FDA Class III recall involving a labeling/specification defect without reported illness or injury. Failed dissolution in an extended-release formulation is a manufacturing quality issue that may result in suboptimal drug performance, warranting a moderate classification but not rising to high severity absent evidence of harm or a higher FDA classification.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Equate Allergy Relief D Extended-Release Tablets due to failed dissolution specifications. The product contains Fexofenadine HCl 60mg (antihistamine) and Pseudoephedrine HCl 120mg (nasal decongestant).

The recall includes two package sizes: 20-count boxes (NDC 49035-273-20) and 30-count boxes (NDC 49035-273-30). A total of 137,856 boxes were distributed nationwide in the USA by Walmart Inc., Bentonville, AR. The affected lot numbers and expiration dates are: 20-count: 79C002624A (Exp. 4/30/2022), AC2000968B (Exp. 8/31/2022), AC2103328F, AC2103330E (Exp. 1/31/2023), and AC2106452I (Exp. 3/31/2023); 30-count: 79C002625A (Exp. 4/30/2022), AC2103328E, AC2103330F (Exp. 1/31/2023), and AC2106452G (Exp. 3/31/2023).

Consumers who have purchased this product should stop use and consult their healthcare provider or pharmacist with questions.

The recalled product

Product
equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart In
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Allergy / Decongestant
Hazard
  • failed-dissolution
  • manufacturing-defect

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 (14)

  • Lot #s: a) (20-count): 79C002624A
  • Exp. 4/30/2022
  • AC2000968B
  • Exp. 8/31/2022
  • AC2103328F
  • AC2103330E
  • Exp.1/31/2023
  • AC2106452I
  • Exp. 3/31/2023. b) (30-count): 79C002625A
  • AC2103328E
  • AC2103330F
  • Exp. 1/31/2023
  • AC2106452G
  • Exp. 3/31/2023.

Distribution

Distributed nationwide across the United States.

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