Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Ph...

FDA Drug Recall #D-0299-2020 — Class II — September 27, 2019

Recall Summary

Recall Number D-0299-2020
Classification Class II — Moderate risk
Date Initiated September 27, 2019
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Taro Pharmaceuticals U.S.A., Inc.
Location Hawthorne, NY
Product Type Drugs
Quantity 639,325 bottles

Product Description

Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9

Reason for Recall

Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing.

Distribution Pattern

U.S.A. Nationwide

Lot / Code Information

Lot #: J78402968, J784129698, Exp 9/19; K765129698, K765229698, K765329698, K769329698, K778829698, K778929698, Exp 10/19; A887230568, A887330568, A887430568, Exp 12/19; B865430568, B865530568, B865630568, B869530568, B869630568, Exp 1/20; D866431198, D866531198, D866631198, D866731198, D866831198, D866931198, D872631198, D872731198, D872831198, D872931198, D873031834, Exp 3/20; E875331834, E875431834, E883831834, E883931834, E884031834, E884131834, Exp 4/20; F865131834, Exp 5/20; G879432436, G879532436, G879632436, G879732436, G879832436, G879932436, G881632436, G882232436, Exp 6/20; H865232436, H865332436, H870832436, Exp 7/20; I885233156, I885333156, I885433156, I885533156, I885633156, I885733164, Exp 8/20; J868533164, J868633164, J868733164, J868833164, J868933164 and J869033164, Exp 9/20; L866434042, L866534043, L866634044, L866734045, L866834046, L866934422, Exp 11/20; A973134748, A973234423, A973334424, A979534425, A979634426, A979734427, A979834428, Exp 12/20; B974034749, B974134750, B974234751, B974334752, B974434753, Exp 1/21

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

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

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.