FDA Drug recall D-0115-2025
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack
- FDA Drug
- Class II
- terminated
- Published 2024-12-18
On 2024-12-18 the FDA classified a Class II recall of Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack by Lnk International, citing CGMP Deviations: Released product should have been rejected.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0115-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-11-14 |
| Published | 2024-12-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lnk International |
| Distribution | US |
Product
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81
Reason
CGMP Deviations: Released product should have been rejected.
Identifiers
| ndc | 63981-795-81 |
|---|---|
| code_info | Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Lnk International
- NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ E…
FDA Drug · Class III · 2022-10-26 · Lnk International - Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Dr…
FDA Drug · Class III · 2022-09-07 · Lnk International - Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Berg…
FDA Drug · Class III · 2021-07-28 · Lnk International - Equate Night-time Sleep Aide (Diphenhydramine HCl), 50 mg, Alcohol Free, Berry Flavor, 12 Fl. Oz. (354 mL), OTC, Distributed by: Walmart St…
FDA Drug · Class II · 2019-08-07 · Lnk International - Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC --- Distributed…
FDA Drug · Class II · 2014-12-31 · Lnk International
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0115-2025%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.