Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Released product should have been rejected.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
63981-0795-81
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine Category: Pain Relief & OTC Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Severe Cold and Flu Plus Congestion Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Guaifenesin, Phenylephrine HCl NDC 63981-0795 |
Kit | Costco Wholesale Corporation | OTC |
- Recalling firm
- LNK International, Inc.
- NDC code
- 63981-795-81
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0115-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenylephrine recalls
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Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
Other recalls by LNK International, Inc.
All 2024 recalls
Class III · Low risk
NDC 0363-6171-09 Walgreens Sinus Pressure
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Class III · Low risk
Nighttime Sleep-Aid
Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate HCl, however the product is doxylamine succinate.
Class III · Low risk
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Class II · Moderate risk
Equate Night-time Sleep Aide
Microbial contamination of non-sterile product
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