The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0382-2022·Announced 2022-01-26

Dr. Reddy's Fexofenadine/Pseudoephedrine Tablets Fail Dissolution Specification

Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets because the tablets failed to meet dissolution specifications, which may affect the drug's effectiveness.

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 involving a dissolution specification failure. The source text does not report any illnesses, injuries, or deaths. The defect is a manufacturing quality issue that may reduce drug effectiveness but does not pose an immediate safety hazard, placing it in the moderate category per the rubric.

Plain-English summary

Dr. Reddy's Laboratories, Inc. is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets USP due to failed dissolution specifications. The affected products include three box sizes: 10-tablet boxes (UPC 343598823355, Lot AC2103328D, Exp. 1/31/2023), 20-tablet boxes (UPC 343598823140, Lot AC2000968C, Exp. 8/31/2022), and 30-tablet boxes (UPC 343598823317, Lots AC2103330C Exp. 1/31/2023 and AC2106452D Exp. 3/31/2023). A total of 9,912 boxes were distributed nationwide in the USA. The tablets were manufactured in India.

When a tablet fails dissolution specifications, the active ingredients may not dissolve properly in the body, potentially reducing the drug's therapeutic effectiveness. Consumers should consult their healthcare provider before discontinuing use of this medication.

The recalling firm is Dr. Reddy's Laboratories, Inc., located in Princeton, New Jersey. This is an FDA Class III recall.

The recalled product

Product
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ…
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Antihistamine / Decongestant Combination
Hazard
Affected units
9,912

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: a) (10-count): AC2103328D
  • Exp. 1/31/2023. b) (20-count) :AC2000968C
  • Exp. 8/31/2022. c) (30-count): AC2103330C
  • Exp. 1/31/2023
  • AC2106452D
  • 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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