Cold & Cough Medicine recalls

The FDA has published 310 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 recalls310since 2012

Last 12 months22reported

Class I206% of total

Ongoing41latest 6 May 2026

Recalls per month, last 24 months

click a bar for that month

4Oct '24 2 0 1Jan '25 2 1 1Apr 0 0 0Jul 0 0 0Oct 0 1 5Jan '26 0 0 15Apr 1 0 0Jul 0 0

Severity split

Class I 20 6%Class II 253 82%Class III 37 12%

Why cold & cough medicine is recalled

Companies

SCA Pharmaceuticals3010%
Central Admixture Pharmacy Services237%
Xiamen Kang Zhongyuan Biotechnology Co155%
Aidapak Services134%
Pharmedium Services114%
Nephron Sterile Compounding Center103%
GlaxoSmithKline Consumer Healthcare;103%
Torrent Pharma93%

Brands

By year

2026217%
202562%
2024248%
20234214%
20223511%
2021134%
202041%
20193913%
2018175%
2017175%

Ongoing cold & cough medicine recalls

41 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 Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	MGC Health, Menthol- Cough Suppressant, Oral Anesthetic recalledMgc Health	Xiamen Kang Zhongyuan Biotechnology Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol-Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	caring mill, Menthol Cough Suppressant Oral Anesthetic recalledCaring Mill Cough Drops Cherry	Xiamen Kang Zhongyuan Biotechnology Co	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 Co	Processing Deviation	Nationwide

All cold & cough medicine recalls, newest first

310 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 Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	MGC Health, Menthol- Cough Suppressant, Oral Anesthetic recalledMgc Health	Xiamen Kang Zhongyuan Biotechnology Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol-Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	caring mill, Menthol Cough Suppressant Oral Anesthetic recalledCaring Mill Cough Drops Cherry	Xiamen Kang Zhongyuan Biotechnology Co	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 Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	exchange select, Menthol- Cough Suppressant Oral Anesthetic recalledMenthol Flavor Cough Drop	Xiamen Kang Zhongyuan Biotechnology Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Pectin Oral Demulcent recalledQuality Choice Cough Drops Creamy Strawberry	Xiamen Kang Zhongyuan Biotechnology Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol- Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology Co	Processing Deviation	Nationwide
22 Apr 2026Drug	CLASS II	QC Quality Choice, Menthol-Cough Suppressant Oral recalledQuality Choice	Xiamen Kang Zhongyuan Biotechnology Co	Processing Deviation	Nationwide

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: 41

Drug classes

Injectable & IV Drugs 4,610Pain Medication 1,517Creams, Ointments & Gels 928Blood Pressure Medication 836Compounded Drugs 721Eye Drops 591Hormones & Birth Control 494Antibiotics 492Allergy Medication 347Stomach & Acid Reflux Medication 313Cold & Cough Medicine 310Diabetes Medication 242

Recall classes

CLASS ISerious harm or death possible.

CLASS IITemporary or reversible harm.

CLASS IIIUnlikely to cause harm.