CLASS II Drug recall · Reported 16 Oct 2019 · FDA Enforcement Report
DrKids Children's Natural Cough Syrup English Ivy Leaf recalled
Unipharma is recalling DrKids Children's Natural Cough Syrup English Ivy Leaf, distributed nationwide in the US. The recall was initiated on 23 Sep 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-0132-2020
- FDA event ID
- 83881
- Recalling firm
- Unipharma, Tamarac, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2019
- FDA classified
- 9 Oct 2019
- Reported
- 16 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cold & Cough Medicine
Timeline
| 23 Sep 2019 | Recall initiated by company | |
| 9 Oct 2019 | Classified by FDA | +16 days |
| 16 Oct 2019 | Published in enforcement report | +7 days |
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 Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026
Where it was distributed
U.S.A. Nationwide
Questions about this recall
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?
Lot: 80047 Exp. 07/31/20
Where was it sold?
U.S.A. 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 83881This product is part of a recall event; the main page for the event is DrKids Himasal Natural Nasal Saline Solution recalled by Unipharma.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DrKids Himasal Natural Nasal Saline Solution recalled by Unipharma | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Unipharma
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DrKids Himasal Natural Nasal Saline Solution recalled by Unipharma | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |
| 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 recalled | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | DrKids Children's Natural Cough Syrup English Ivy Leaf recalled | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |