The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0381-2022·Announced 2022-01-26

Fexofenadine/Pseudoephedrine tablets recalled for failed dissolution

Dr. Reddy's Laboratories is recalling Kroger Allergy Relief-D tablets (fexofenadine HCl 60mg/pseudoephedrine HCl 120mg) due to failed dissolution specifications. Approximately 11,064 boxes distributed nationwide are affected.

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. The source text identifies only a failed dissolution specification without reports of illness or injury. No clinical harm has been reported, making this a precautionary recall grounded in a manufacturing or quality-control issue rather than confirmed adverse events.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Kroger Allergy Relief-D Extended-Release Tablets, which contain fexofenadine HCl 60mg (antihistamine) and pseudoephedrine HCl 120mg (nasal decongestant), due to failed dissolution specifications. The affected product is NDC 30142-611-14, 20 tablets per box, manufactured in India and distributed by the Kroger Co.

Approximately 11,064 boxes with the following lot numbers have been distributed nationwide: AC2000968E (expiration 8/31/2022), AC2103328A (expiration 1/31/2023), AC2103330I (expiration 1/31/2023), and AC2106452B (expiration 3/31/2023).

Consumers who have purchased this product should stop using it and dispose of it safely. Persons with questions about this recall may contact Dr. Reddy's Laboratories or consult a healthcare provider.

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 — Over-the-counter oral antihistamine/decongestant
Hazard
Affected units
11,064

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 (7)

  • Lot #s: AC2000968E
  • Exp. 8/31/2022
  • AC2103328A
  • AC2103330I
  • Exp. 1/31/2023
  • AC2106452B
  • Exp. 3/31/2023.

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 →

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