Acetaminophen suspension liquid — Class II drug recall D-004-2014
Terminated recall by L. Perrigo Co., reported 2013-11-27, distributed nationwide. Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an or
| Recall number | D-004-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | L. Perrigo Co., Allegan, MI, United States |
| Recall initiated | 2013-11-01 |
| Classified | 2013-11-20 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 35,136 bottles |
| UPC / GTIN / UDI-DI | 00041220880669, 00041260358319, 00052569132487, 00096295120950, 00311917132211, 00717851200946, 00725439958141 |
| NDC | 00363-0161-16, 30142-0161-16, 37205-0577-16, 37808-0161, 37808-0161-16, 51334-0161-16, 55316-0161-16, 62011-0002-01 |
| Lot numbers | 06/15, 07/15, 08/15, 3HK0671, 3JK0610, 3KK0606 |
Product
Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever acetaminophen suspension, Distributed by Cardinal Health, Dublin, Ohio 43017, NDC 37205-577-16, UPC 0 96295 12095 0; b) Walgreens infants' Pain & Fever acetaminophen oral suspension, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0161-16, UPC 3 11917 13221 1; c) Kroger Infants' Pain & Fever acetaminophen suspension liquid, Distributed by The Kroger Co., Cincinnati, Ohio 45202, NDC 30142-161-16, UPC 0 41260 35831 9; d) H-E-B Pain & Fever acetaminophen suspension Infants', Made With Pride & Care For H-E-B, San Antonio, TX 78204, NDC 37808-161-16, UPC 0 41220 88066 9; e) Babies R Us Infants' Pain & Fever acetaminophen suspension, Distributed by Toys R Us, Inc., Wayne, NJ 07470, NDC 51334-161-16, UPC 7 17851 20094 6; f) healthy accents infants' pain & fever acetaminophen suspension liquid, Distributed By: DZA Brands, LLC, Salisbury, NC 28147/Scarborough, ME 04074, NDC 55316-161-16, UPC 7 25439 95814 1; g) Health Mart Pharmacy infants' pain & fever acetaminophen suspension liquid, Distributed by McKesson, One Post Street, San Francisco, CA 94104, NDC 62011-0002-1, UPC 0 52569 13248 7
Reason for recall
Defective Delivery System: There is a remote potential that cartons of product could be co-packaged with an oral dosing syringe without dose markings.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-004-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.