CVS Children's Acetaminophen Recalled for Potential B. cepacia Contamination
Unipharma is recalling CVS Health Children's Pain & Fever Acetaminophen single-use vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is explicitly described as a 'precautionary measure' due to 'potential risk' of contamination, with no reported illnesses or injuries, which aligns with the rubric for voluntary precautionary recalls.
Plain-English summary
Unipharma, Llc. is recalling CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL single-use vials. The recall is a precautionary measure taken due to potential risk of product contamination with the bacteria B. cepacia.
The affected product is distributed by CVS Pharmacy, Inc. and is identified by NDC 69842-0258-01 and UPC 050428601891. The specific lot number is 80061 with an expiration date of 11/30/20. A total of 15,264 cartons were distributed nationwide and in Venezuela.
Consumers should stop using the product and return it to the point of purchase or contact the recalling firm for further instructions.
The recalled product
- Product
- CVS Health Children's Pain & Fever Acetaminophen 160 mg/5 mL Pain reliever/Fever reducer Single-Use Vials Cherry Flavor 20 Single-Use Vials per carton 0.17 fl. oz. (5 mL), Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, NDC 69842-0258-01, UPC 050428601891
- Manufacturer
- Unipharma, Llc.
- Category
- Drug — Pediatric Analgesic
- Hazard
- Affected units
- 15,264
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 80061 Exp. 11/30/20
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Unipharma, Llc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 11 products in this recall →Related recalls
Same manufacturer · Unipharma, Llc.
See all →- ModerateDrKids Children's Natural Cough Syrup Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-10-16
- SevereDrKids Himasal Nasal Saline Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-10-16
- ModerateCVS Children's Allergy Relief Liquid Medication Recalled for Potential B. cepacia Contamination
FDA (Drugs) · 2019-08-14
- ModerateCVS Children's Nasal Saline Drops Recalled for B. cepacia Contamination Risk
FDA (Drugs) · 2019-08-14
- ModerateUnipharma Recalls DrKids Children's Allergy Relief Diphenhydramine Due to B. cepacia Risk
FDA (Drugs) · 2019-08-14
Same hazard · bacterial contamination
See all →- HighClorox Recalls Scented Mistolin and Lestoil Cleaners in Puerto Rico
CPSC · 2026-09-03
- HighCurry chicken salad flagged for possible Listeria contamination in two states
USDA FSIS · 2026-07-30
- ModerateMedline Medical Convenience Kits Recalled Due to Potential Bacillus Contamination
FDA (Devices) · 2026-07-29
- HighMedline Convenience Kits Recalled Over Bacillus Contamination
FDA (Devices) · 2026-07-29
- SevereSurgical Convenience Kit Recalled for Bacterial Contaminant in Alcohol Prep Pads
FDA (Devices) · 2026-07-08