CLASS II Drug recall · Reported 22 May 2019 · FDA Enforcement Report
DrKids Children's Allergy Relief Diphenhydramine HCl 5 mg recalled
Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine HCl 5 mg/ Antihistamine, 20 Pre-measured, distributed nationwide in the US. The recall was initiated on 2 May 2019 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-1298-2019
- FDA event ID
- 82754
- Recalling firm
- Unipharma, Tamarac, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2019
- FDA classified
- 23 May 2019
- Reported
- 22 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Allergy Medication
Timeline
| 2 May 2019 | Recall initiated by company | |
| 22 May 2019 | Published in enforcement report | +20 days |
| 23 May 2019 | Classified by FDA | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Product as listed by the FDA
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, 20 Pre-measured Single-Use Vials, 0.17 fl. oz. (5 mL), Mixed Berry, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, NDC 70302-012-20, UPC 370302255010
Where it was distributed
Nationwide and Venezuela
Questions about this recall
Is DrKids Children's Allergy Relief Diphenhydramine HCl 5 mg/ Antihistamine, 20 Pre-measured recalled?
Yes. Unipharma recalled DrKids Children's Allergy Relief Diphenhydramine HCl 5 mg/ Antihistamine, 20 Pre-measured on 2 May 2019. The recall is Class II and its status is Terminated. Recall number D-1298-2019.
Why was it recalled?
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Which lots are affected?
Lots: 80058; 80060, Exp. 11/30/20
Where was it sold?
Nationwide and Venezuela
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.
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|---|---|---|---|---|---|
| Drug | CLASS II | DrKids Children's Natural Cough Syrup English Ivy Leaf recalled | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS II | CVS Health Children's Nasal Saline Drops recalled by Unipharma | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | CVS Health Children's Allergy Relief Liquid Medication recalled | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | DrKids Children's Allergy Relief Diphenhydramine HCl 5 mg recalled | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |