The Recall Desk
LowFDA (Drugs)·D-0380-2022·Announced 2022-01-26

Rite Aid Allergy & Congestion Tablets Fail Dissolution Specifications

Rite Aid Pharmacy is recalling Allergy & Congestion extended-release tablets because two lots failed to meet dissolution specifications. The affected product was distributed nationwide.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: This is an FDA Class III recall for a manufacturing defect (failed dissolution specifications) with no reported illnesses or injuries. Per the rubric, FDA Class III recalls are typically scored 1 or 2; absent any evidence of actual harm, the score is 1.

Plain-English summary

Rite Aid Pharmacy is recalling Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP in 20-tablet boxes (UPC 011822738873) due to failed dissolution specifications. The manufacturer, Dr. Reddy's Laboratories, Inc., identified that certain lots did not dissolve properly according to required standards.

Two specific lots are affected: Lot #AC2103330D (Expiration 1/31/2023) and Lot #AC2106452E (Expiration 3/31/2023). Approximately 7,080 boxes were distributed nationwide in the USA by Rite Aid, 30 United Lane, Camp Hill, PA 17011. The tablets were manufactured in India.

Consumers who have purchased this product and have the affected lot numbers should stop using them and contact their pharmacy or healthcare provider for guidance. Consumers may also contact Dr. Reddy's Laboratories customer service or return the product to the place of purchase.

The recalled product

Product
Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India.
Manufacturer
Dr. Reddy's Laboratories, Inc.
Category
Drug — Over-the-Counter Allergy & Decongestant
Hazard
Affected units
7,080

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 (4)

  • Lot #: AC2103330D
  • Exp.1/31/2023
  • AC2106452E
  • 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 →

Related recalls

Same manufacturer · Dr. Reddy's Laboratories, Inc.

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Same hazard · dissolution failure

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