Infants Pain and Fever acetaminophen recalled for contaminated excipient
Perrigo Company is recalling Infants Pain and Fever acetaminophen oral suspension (160mg/5ml) distributed nationwide due to contamination from a recalled excipient supplier. The product was manufactured with a contaminated ingredient that does not meet manufacturing standards.
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: This is an FDA Class II recall of an over-the-counter drug. The source text indicates a manufacturing deviation related to a contaminated excipient from a recalled supplier, but does not report any illnesses, injuries, or hospitalizations. This is a precautionary recall based on manufacturing compliance issues.
Plain-English summary
Perrigo Company PLC is recalling Infants Pain and Fever acetaminophen dye-free grape oral suspension, 160mg/5ml, in 2 FL OZ (59 mL) bottles distributed nationwide. The recall involves batch 1CK1274 with an expiration date of 02/28/2023 (NDC: 30142-766-16). A total of 5,184 bottles are affected.
The recall was initiated because the products were manufactured using a contaminated excipient (inactive ingredient) that had itself been recalled by the supplier. This represents a deviation from Current Good Manufacturing Practice (CGMP) requirements.
Consumers who have purchased this product should stop use and consult with a healthcare provider or pharmacist regarding safe pain and fever relief alternatives for infants. The product batch, expiration date, and NDC number are provided above to assist in identification.
The recalled product
- Product
- INFANTS PAIN AND FEVER (ACETAMINOPHEN)
- Brand
- INFANTS PAIN AND FEVER
- Manufacturer
- Perrigo Company PLC
- Affected units
- 5,184
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 (2)
- Batch: 1CK1274
- Exp 02/28/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Perrigo Company PLC 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 51 products in this recall →Related recalls
Same brand · INFANTS PAIN AND FEVER
- HighKinderFarms Infants' Acetaminophen Recalled for Failed Impurity and Degradation Standards
FDA (Drugs) · 2023-12-13
- ModerateInfants Pain and Fever Acetaminophen recalled for contaminated excipient
FDA (Drugs) · 2022-03-02
Same manufacturer · Perrigo Company PLC
See all →- ModerateCareOne Severe Congestion Nasal Spray Recalled Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateEquate Children's Pain and Fever Acetaminophen Suspension Recall
FDA (Drugs) · 2022-03-02
- ModerateEqualine Nasal Oxymetazoline HCl Nasal Spray Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateUP AND UP Childrens Acetaminophen Recall Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
- ModerateCVS Infant's Grape Acetaminophen Suspension Recalled for Contaminated Excipient
FDA (Drugs) · 2022-03-02
Same hazard · contamination
See all →- HighMedline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 263 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline recalls surgical convenience kits due to potential contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 663 Surgical Convenience Kits Due to Contamination
FDA (Devices) · 2026-09-02
- HighMedline Recalls 71 Convenience Kits Due to Contaminated Component
FDA (Devices) · 2026-09-02