# FDA recall D-0115-2025

> **LNK International, Inc.** · Class II · drug recall initiated 2024-11-14.

## 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 for recall

CGMP Deviations: Released product should have been rejected.

## Distribution

Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.

## Key facts

- **Recall number:** D-0115-2025
- **Recalling firm:** LNK International, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-11-14
- **Report date:** 2024-12-18
- **Termination date:** 2025-09-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hauppauge, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0115-2025

## Citation

> AI Analytics. FDA recall D-0115-2025. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/D-0115-2025. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*