FDA drug recalls · openFDA

Is FEXOFENADINE HYDROCHLORIDE recalled?

The FDA has recorded 11 recalls of FEXOFENADINE HYDROCHLORIDE (2023–2024) , recalled under brands like ALLERGY RELIEF, BASIC CARE ALLERGY, BERKLEY JENSEN ALLERGY RELIEF. 1 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of FEXOFENADINE HYDROCHLORIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Failed Impurities/Degradation Specifications 10

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998- Class II Completed

SUN PHARMACEUTICAL INDUSTRIES INC 2024-01-18 lots: Lot #s: a) DNE0792A Exp. 06/31/2025; DNE1027A Exp. 08/31/2025. b) DNE0793A Exp. 06/31/2025. c) DNE0789A, DNE0790A, DNE0791A Exp. 06/2025, DNE1026A Exp. 08/31/025.

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-cou Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot #: a) 2FV1948, 2ER0285, 2ER0411, Exp. Date 01/24 b)2CR0653, Exp. Date 12/23 c)2GR0331, Exp. Date 04/24

allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45- Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot #: a) 2CR0652, 2DR0464, 2DR0465,Exp. Date 12/23; 2ER0285, Exp. Date 01/24. b) 2DR0466, Exp. Date 12/23; 2ER0412, Exp. Date 01/24; 2GR0330, Exp. Date 04/24

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-coun Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot #: a) 2JE1882, Exp. date 01/24 b) 2FV1918, 2ER0411, Exp. date 01/24; 2GV1902, Exp. date 04/24; 2CR0652, 2DR0465, Exp. date 12/23; 2GR0329, Exp. date 04/24 c)2CR0653, 2DR0466, Exp. date 12/23; 2ER0287, 2ER0412, Exp. date 01/24

Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847 Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot #: 2DR0351, Exp. date 12/23

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, S Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot #: 2JE2185, Exp. date 01/24

Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot #: a) 2DV1869, 2EV1613, 2EV1614, Exp. date 12/23; 2EV1820, 2FV1943, Exp. date 01/24; 2GV1893, Exp. date 04/24. Lot #: b) 2CR0653, 2DR0466, Exp. date 12/23, 2ER2087, Exp. date 01/24

Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot # a) 2GR0329, Exp. date 04/24 Lot # b) 2DR0472, Exp. date 02/23; 2MR0417, Exp. date 07/24

Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot #:2DV1863, 2HV2698, Exp. date 12/23; 2GV1583, Exp. date 02/24; 2GV1950, 2HV2697, Exp. Date 01/24.

Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave. Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot #: 2DV1487, 2DV1870, 2DV1871, 2DV1873, 2EV1676, 2GV2132, 2HV2679, Exp. date 12/23; 2DV2000, exp. date 11/23; 2LV1573, 2MV1314, Exp. date 04/24; 2FV1764, 2FV1765 2FV1766, 2GV1579, 2GV1937, 2GV1941 , 2GV1942, 2GV2157, 2HV1886, 2HV1997, 2HV2019, 2HV2047, Exp. datev02/24; 2EV1666, 2EV1667, 2EV1668, 2EV1670, 2EV1671, 2EV1672, 2EV1674, 2EV1677, 2EV1678, 2HV2017, Exp. date 01/24.

aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Per Class II Terminated

L. Perrigo Company 2023-02-09 lots: Lot #: 2ER0285,Exp. date 01/24

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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