Unipharma, Llc. recalls DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured
Unipharma recalls DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL antihistamine due to potential contamination with bacteria B. cepacia. This precautionary recall affects 20-pre-measured vials manufactured in the USA.
Lower-risk recall
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Contact the company & request your remedy
What happened, in plain English
Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL antihistamine vials because of potential contamination with bacteria B. cepacia. This recall is a precautionary measure to prevent possible health risks from consuming the contaminated product. Read more at govinfonow.com/recall/38281-unipharma-drkids-allergy-relief-diphenhydramine-recall-b-cepacia-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38281-unipharma-drkids-allergy-relief-diphenhydramine-recall-b-cepacia-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1632-2019
Cite this page
“Unipharma DrKids Allergy Relief Diphenhydramine Recall: B. cepacia Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38281-unipharma-drkids-allergy-relief-diphenhydramine-recall-b-cepacia-contamination-risk. Based on FDA recall #D-1632-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1632-2019%22&limit=1).
Why it’s dangerous
The product was manufactured under CGMP (Current Good Manufacturing Practices) deviations, leading to potential contamination with bacteria B. cepacia. This bacteria could cause health issues if ingested, though the recall is precautionary and not based on confirmed cases of illness.
Who’s affected
Parents and caregivers who purchased the DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL antihistamine vials from the manufacturer. Children using this product are most at risk due to potential bacterial contamination.
How to tell if you have this one
Check for DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL antihistamine vials with the Mixed berry flavor, 20 pre-measured single-use vials per carton. The product was manufactured in the USA by Unipharma, LLC in Tamarac, FL with lot number 90003 and expiration date 01/31/21.
- Brand
Unipharma- Product
DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the US.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1631-2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156; Lot: 80060 Exp. 11/30/20 | 48 cartons |
| D-1632-2019 | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured Single-Use vials per Carton, Manufactured in USA by: Unipharma, LLC. Tamarac, FL 33321, UPC 370302255010; Lot: 90003 Exp. 01/31/21 | 432 cartons |
| D-1633-2019 | CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moisturizer, 30 single-use vials per Carton,0.05 fl. oz. (1.5 mL) each 1.5 fl. oz. (45 mL) total, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, UPC 050428598207; Lot: 90008 Exp. 02/28/21 | 48 cartons |
What to do — step by step
Check Product Details
Look for the product name, flavor, and quantity on the vial label to confirm it matches the recalled items.
Questions people ask
Is this product safe to use?
The recall is precautionary due to potential contamination with bacteria B. cepacia. The manufacturer has not reported confirmed cases of illness, but the product should not be used until the recall is resolved.
What should I do if I have the recalled product?
The recall does not specify a remedy, so you should check with Unipharma for guidance on safe disposal or return options.
How can I tell if I have the recalled product?
Check for DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL antihistamine vials with Mixed berry flavor, 20 pre-measured single-use vials per carton, manufactured by Unipharma, LLC in Tamarac, FL with lot number 90003 and expiration date 01/31/21.
Contact Unipharma
We’ve drafted a message you can send Unipharma to request your refund or repair — edit it as you like.
Subject: Recall D-1632-2019 — Unipharma DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed be Hello, I own a DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistamine, Mixed berry Flavor, 20 Pre-measured that is covered by recall D-1632-2019 from Unipharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1632-2019 (July 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1632-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.