CLASS II Drug recall · Reported 11 Feb 2015 · FDA Enforcement Report
Children's Loratadine Syrup recalled by Taro Pharmaceuticals U.S.A
Taro Pharmaceuticals U.S.A is recalling Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/, Antihistamine, Grape, distributed nationwide in the US. The recall was initiated on 30 Dec 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0383-2015
- FDA event ID
- 70183
- Recalling firm
- Taro Pharmaceuticals U.S.A, Hawthorne, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Dec 2014
- FDA classified
- 5 Feb 2015
- Reported
- 11 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Allergy Medication
Timeline
| 30 Dec 2014 | Recall initiated by company | |
| 5 Feb 2015 | Classified by FDA | +37 days |
| 11 Feb 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL, Antihistamine, Grape Flavored Syrup, 24 Hour Non-Drowsy Allergy Relief Sugar Free, 4 FL OZ (120 mL) Bottles, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC: 51672-2092-8.
Where it was distributed
Nationwide
Questions about this recall
Is Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/, Antihistamine, Grape recalled?
Yes. Taro Pharmaceuticals U.S.A recalled Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/, Antihistamine, Grape on 30 Dec 2014. The recall is Class II and its status is Terminated. Recall number D-0383-2015.
Why was it recalled?
Presence of Foreign Substance: Presence of blue plastic floating in loratadine syrup.
Which lots are affected?
Lot #: A4105, Exp 12/2016
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Taro Pharmaceuticals U.S.A
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|---|---|---|---|---|---|
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| Drug | CLASS II | Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride | Taro Pharmaceuticals U.S.A | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHeb | Taro Pharmaceuticals U.S.A | Potency & Assay | Nationwide |