CLASS II Drug recall · Reported 14 Aug 2019 · FDA Enforcement Report
CVS Health Children's Allergy Relief Liquid Medication recalled
Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/ Oral, distributed nationwide in the US. The recall was initiated on 15 Jul 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-1631-2019
- FDA event ID
- 83492
- Recalling firm
- Unipharma, Tamarac, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jul 2019
- FDA classified
- 8 Aug 2019
- Reported
- 14 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Allergy Medication
Timeline
| 15 Jul 2019 | Recall initiated by company | |
| 8 Aug 2019 | Classified by FDA | +24 days |
| 14 Aug 2019 | 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
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
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
Where it was distributed
Nationwide in the US.
Stores named: CVS
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: 80060 Exp. 11/30/20
Where was it sold?
Nationwide in the US.
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
2 other products · FDA event 83492This product is part of a recall event; the main page for the event is DrKids Children's Allergy Relief Diphenhydramine HCl recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DrKids Children's Allergy Relief Diphenhydramine HCl recalled | Unipharma | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | CVS Health Children's Nasal Saline Drops recalled by Unipharma | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Unipharma
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DrKids Children's Natural Cough Syrup English Ivy Leaf recalled | Unipharma | Manufacturing (CGMP) Deviations | Nationwide |
| 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 | 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 |