FDA Drug recall D-1631-2019
CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 2…
- FDA Drug
- Class II
- terminated
- Published 2019-08-14
On 2019-08-14 the FDA classified a Class II recall of CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 2… by Unipharma, citing CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1631-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-15 |
| Published | 2019-08-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unipharma |
| Distribution | US |
Product
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
Reason
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Identifiers
| upc | 050428597156 |
|---|---|
| code_info | Lot: 80060 Exp. 11/30/20 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1631-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.