Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0068-2022·Announced 2021-11-03

Loratadine-D Extended-Release Tablets Recalled for Failed Moisture Limits

Sun Pharmaceutical Industries is recalling 22,752 blister packs of Loratadine-D Extended-Release Tablets (10mg/240mg) distributed nationwide due to failed moisture limits. The affected lot is AC14635 with expiration date 12/2022.

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 for a labeling/packaging-related quality defect (failed moisture limits) with no reported illnesses or injuries. Per the rubric, Class III recalls are typically scored 1 or 2, and moisture control issues represent a manufacturing defect rather than an acute safety hazard, warranting a Moderate classification.

Plain-English summary

Sun Pharmaceutical Industries Inc is recalling Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) in 10-count blister packs. The recall affects 22,752 blister packs distributed nationwide within the United States.

The recall is due to failed moisture limits. The affected product is Lot #AC14635 with expiration date 12/2022, NDC 0904-5833-15, distributed by Major Pharmaceuticals.

Consumers who have purchased this product should contact their pharmacy or healthcare provider for guidance. Consumers with questions may contact the manufacturer.

The recalled product

Product: LORATADINE AND PSEUDOEPHEDRINE SULFATE (LORATADINE AND PSEUDOEPHEDRINE SULFATE)
Brand: LORATADINE AND PSEUDOEPHEDRINE SULFATE
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Category: Drug — Over-the-Counter Antihistamine-Decongestant
Hazard: moisture-control-failure
product-stability
Affected units: 22,752

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 (2)

Lot #: AC14635
Exp. Date 12/2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by SUN PHARMACEUTICAL INDUSTRIES 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 2 products in this recall →

Same brand · LORATADINE AND PSEUDOEPHEDRINE SULFATE

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Ohm Laboratories Recalls Loratadine and Pseudoephedrine Sulfate Tablets Due to Blister Defects
FDA (Drugs) · 2014-04-30

Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

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