Cold & Cough Medicine recalls

The FDA has published 312 recalls involving cold & cough medicine since 2012. The latest was reported on 6 May 2026. Most were for sterility. SCA Pharmaceuticals has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls312since 2012

Last 12 months22reported

Class I206% of total

Ongoing43latest 6 May 2026

Recalls per month, last 24 months

click a bar for that month

4Nov '24 0 1 2Feb 1 1 0May 0 0 0Aug 0 0 0Nov 1 5 0Feb 0 15 1May 0 0 0Aug 0 0

Severity split

Class I 20 6%Class II 253 81%Class III 39 13%

Why cold & cough medicine is recalled

Companies

SCA Pharmaceuticals3010%
Central Admixture Pharmacy Services237%
Xiamen Kang Zhongyuan Biotechnology155%
Aidapak Services134%
Pharmedium Services114%
Nephron Sterile Compounding Center103%
GlaxoSmithKline Consumer Healthcare;103%
Torrent Pharma93%

Brands

By year

2026217%
202562%
2024268%
20234213%
20223511%
2021134%
202041%
20193913%
2018175%
2017175%

Ongoing cold & cough medicine recalls

43 active

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS II	Phenylephrine Hydrochloride Injectable Solution, 40mg recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol- Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	MGC Health, Menthol- Cough Suppressant, Oral Anesthetic recalledMgc Health	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol-Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	caring mill, Menthol Cough Suppressant Oral Anesthetic recalledCaring Mill Cough Drops Cherry	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol-Cough Suppressant Oral recalledQuality Choice Cough Drops Vanilla Honey	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide

All cold & cough medicine recalls, newest first

312 total

Reported	Class	Recall	Company	Reason	Where
6 May 2026Drug	CLASS II	Phenylephrine Hydrochloride Injectable Solution, 40mg recalled	Wells Pharma of Houston	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol- Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	MGC Health, Menthol- Cough Suppressant, Oral Anesthetic recalledMgc Health	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol-Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	caring mill, Menthol Cough Suppressant Oral Anesthetic recalledCaring Mill Cough Drops Cherry	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol-Cough Suppressant Oral recalledQuality Choice Cough Drops Vanilla Honey	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	exchange select, Menthol- Cough Suppressant Oral Anesthetic recalledMenthol Flavor Cough Drop	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Pectin Oral Demulcent recalledQuality Choice Cough Drops Creamy Strawberry	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol- Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol-Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	Discount Drug Mart Food Market, Cough Drops recalledDiscount Drug Mart	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol-Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	exchange select, Menthol -Cough Suppressant Oral Anesthetic recalledHoney Lemon Flavor Cough Drop	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	Discount Drug Mart Food Market, Cough Drops recalledDiscount Drug Mart	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	MGC Health, Menthol- Cough Suppressant, Oral Anesthetic recalledMgc Health	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	MGC Health, Menthol- Cough Suppressant, Oral Anesthetic recalledMgc Health	Xiamen Kang Zhongyuan Biotechnology	Processing Deviation	Nationwide
21 Jan 2026Drug	CLASS II	Alka Seltzer, a) Original per packet recalled by Gold Star Distribution	Gold Star Distribution	Foreign Material	Nationwide
21 Jan 2026Drug	CLASS II	Dayquil Cold & Flu recalled by Gold Star Distribution	Gold Star Distribution	Foreign Material	Nationwide
21 Jan 2026Drug	CLASS II	Nyquil Cold & Flu recalled by Gold Star Distribution	Gold Star Distribution	Foreign Material	Nationwide
21 Jan 2026Drug	CLASS II	Halls Cough Drops a), Menthol recalled by Gold Star Distribution	Gold Star Distribution	Foreign Material	Nationwide
21 Jan 2026Drug	CLASS II	Tylenol a) 500 MG., 2'S Display recalled by Gold Star Distribution	Gold Star Distribution	Foreign Material	Nationwide
10 Dec 2025Drug	CLASS II	Phenylephrine HCI, 1000 mcg / Total Volume recalled	Park Avenue Compounding	Manufacturing (CGMP) Deviations	MO
30 Apr 2025Drug	CLASS II	PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled	Denver Solutions	Sterility	Nationwide
19 Mar 2025Drug	CLASS I	PHENYLephrine added to 0.9% sodium chloride, 40 mg/* (160 mcg/mL) recalled	Central Admixture Pharmacy Services	Particulate Matter	Nationwide
26 Feb 2025Drug	CLASS I	Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled	Provepharm	Particulate Matter	Nationwide
12 Feb 2025Drug	CLASS III	Guaifenesin and Codeine Phosphate Oral Solution recalled by PAI HoldingsGuaifenesin And Codeine Phosphate	PAI Holdings	Potency & Assay	OH
8 Jan 2025Drug	CLASS II	phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled	Hikma Injectables USA	Sterility	Nationwide
27 Nov 2024Drug	CLASS II	Guaifenesin Dextromethorphan Syrup, 200 mg/20mg recalled	The Harvard Drug Group	Potency & Assay	Nationwide
27 Nov 2024Drug	CLASS II	Guaifenesin Dextromethorphan Syrup, 100 mg/10mg recalled	The Harvard Drug Group	Potency & Assay	Nationwide
13 Nov 2024Drug	CLASS III	Kids' Cough and Chest Congestion (Dextromethorphan HBr recalledMaximum Strength Cough And Chest Congestion And Nighttime Severe Cold And Flu Combo Pack	Denison Pharmaceuticals	Packaging Defects	RI

Should you stop taking Cold & Cough Medicine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.

Alert me about Cold & Cough Medicine

One email the day a new recall is posted for Cold & Cough Medicine. Unsubscribe any time.

At a glance

Latest recall: 6 May 2026
First on record: 17 Oct 2012
Class I share: 6%
Ongoing: 43

Drug classes

Injectable & IV Drugs 4,626Pain Medication 1,518Creams, Ointments & Gels 930Blood Pressure Medication 837Compounded Drugs 721Eye Drops 600Hormones & Birth Control 495Antibiotics 492Allergy Medication 348Stomach & Acid Reflux Medication 313Cold & Cough Medicine 312Diabetes Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.