Home / Recalls / Taro Pharmaceuticals U.S.A., Inc. / D-0278-2019

D-0278-2019 Class II Terminated

Recalled by Taro Pharmaceuticals U.S.A., Inc. — Hawthorne, NY

FDA drug recall D-0278-2019 was initiated by Taro Pharmaceuticals U.S.A., Inc. on Oct 19, 2018 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing. The recall status is terminated (terminated Nov 3, 2020).

Recall Details

Product Type: Drugs
Report Date: Nov 21, 2018
Initiation Date: Oct 19, 2018
Termination Date: Nov 3, 2020
Voluntary/Mandated: Voluntary: Firm initiated

Product Description

children's allergy relief (cetirizine hydrochloride) oral solution, 1 mg/mL, Dye Free, Sugar Free, Alcohol Free, 4 FL OZ (120 mL) bottle, Distributed by Rite-Aid, 30 Hunter Lane, Camp Hill, PA 17011, Made in Israel, UPC 0 11822 57363 4.

Reason for Recall

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Distribution Pattern

Nationwide in the USA

Code Information

Lot # 313344, Exp 12/18

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0278-2019
openFDA file date: Oct 21, 2026
Loaded by RegDataLab: Oct 23, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Taro Pharmaceuticals U.S.A., Inc.

D-0633-2024 Class III — Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by… (Aug 7, 2024)
D-0727-2022 Class III — Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx… (Feb 25, 2022)
D-0375-2022 Class I — Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro… (Dec 15, 2021)
D-0246-2021 Class II — Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro… (Jan 8, 2021)
D-0150-2021 Class II — CVS Health Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT… (Nov 17, 2020)
D-0157-2021 Class II — Best Choice, Clotrimazole Cream, USP 1%, Antifungal, NET WT 0.5 OZ (14.2g)… (Nov 17, 2020)
D-0155-2021 Class II — Kroger Jock Itch Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT .5… (Nov 17, 2020)
D-0158-2021 Class II — TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal… (Nov 17, 2020)
D-0156-2021 Class II — RiteAid Pharmacy RIngworm Cream, Clotrimazole Cream USP, 1%, Antifungal NET W… (Nov 17, 2020)
D-0159-2021 Class II — Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal Cream, NET WT 1 oz… (Nov 17, 2020)