Fexofenadine Hydrochloride Tablets Recalled for Failed Quality Specifications
L. Perrigo is recalling 32,376 cartons of Good Sense Aller Ease antihistamine tablets nationwide due to failed quality specifications affecting impurities and degradation. Consult your healthcare provider if you have taken this product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving failed quality specifications (impurities and degradation) for an OTC drug. Although no illnesses or injuries have been reported, the recall addresses a risk-of-harm situation where the actual harm to patients has not yet manifested, placing it in the High severity category per the rubric.
Plain-English summary
L. Perrigo Company is recalling 32,376 cartons of Good Sense Aller Ease Fexofenadine Hydrochloride 180 mg tablets due to failed impurities and degradation specifications. The affected tablets are packaged in both 30-count cartons (NDC 0113-0847-39) and 45-count cartons (NDC 0113-0847-95).
The recall affects multiple lot numbers distributed nationwide within the United States. Affected lots for 30-count cartons include 2DV1869, 2EV1613, 2EV1614 (expiring 12/23); 2EV1820, 2FV1943 (expiring 01/24); and 2GV1893 (expiring 04/24). Affected lots for 45-count cartons include 2CR0653, 2DR0466 (expiring 12/23) and 2ER2087 (expiring 01/24).
Consumers who have purchased this product should stop using it and consult their healthcare provider. For questions or to report adverse reactions, contact the FDA or your healthcare provider.
The recalled product
- Product
- GOOD SENSE ALLER EASE (FEXOFENADINE HYDROCHLORIDE)
- Brand
- GOOD SENSE ALLER EASE
- Manufacturer
- L. Perrigo Company
- Category
- Drug — Antihistamine
- Hazard
- Affected units
- 32,376
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 (11)
- Lot #: a) 2DV1869
- 2EV1613
- 2EV1614
- Exp. date 12/23
- 2EV1820
- 2FV1943
- Exp. date 01/24
- 2GV1893
- Exp. date 04/24. Lot #: b) 2CR0653
- 2DR0466
- 2ER2087
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by L. Perrigo Company 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 13 products in this recall →Related recalls
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