children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Su...

FDA Drug Recall #D-0277-2019 — Class II — October 19, 2018

Recall Summary

Recall Number D-0277-2019
Classification Class II — Moderate risk
Date Initiated October 19, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Taro Pharmaceuticals U.S.A., Inc.
Location Hawthorne, NY
Product Type Drugs
Quantity 8328 bottles

Product Description

children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.

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

Lot / Code Information

Lot # 313345, Exp 12/18

Other Recalls from Taro Pharmaceuticals U.S.A., Inc.

Recall # Classification Product Date
D-0633-2024 Class III Hydrocortisone 1% & Acetic Acid 2% Otic Solutio... Aug 7, 2024
D-0727-2022 Class III Clotrimazole and Betamethasone Dipropionate Cre... Feb 25, 2022
D-0375-2022 Class I Clobetasol Propionate Ointment USP, 0.05%, 60g ... Dec 15, 2021
D-0246-2021 Class II Nortriptyline HCl Capsules, USP equivalent to 1... Jan 8, 2021
D-0158-2021 Class II TopCare Health, Athlete's Foot Cream, Clotrimaz... Nov 17, 2020

Frequently Asked Questions

Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.