The Recall Desk
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.

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. 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
  • failed-dissolution
  • quality-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 (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.

Related recalls

Same brand · FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI

Same category