Cough & cold medicine recalls
FDA drug recall list
Cough and cold medicines, including children's syrups, are recalled for contamination, dosing-cup errors, and mislabeling.
FDA data updated Last synced
- Reports mentioning it
- 105
- Class I (serious)
- 11
- Class II
- 80
- Class III
- 14
Key facts: cough & cold medicine recalls
- The FDA has published 105 drug enforcement reports mentioning cough & cold medicine since 2012, as of October 7, 2026.
- 11 of them were Class I, the most serious category, where a product could cause serious health problems or death.
- The most recent was reported on Apr 22, 2026: MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-c… (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.), Class II.
- Source: U.S. Food and Drug Administration enforcement reports via openFDA. See our sources policy.
Latest 94 cough & cold medicine recalls
- Apr 22, 2026MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-c…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- Apr 22, 2026MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Sugar Free, Honey…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- Apr 22, 2026Discount Drug Mart Food Market, Cough Drops, Menthol -Cough Suppressant Anesthetic, 30-…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- Apr 22, 2026exchange select, Menthol -Cough Suppressant Oral Anesthetic, Honey Lemon Flavor Cough D…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- Apr 22, 2026QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free,…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- Apr 22, 2026Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Hon…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- Apr 22, 2026QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Honey Lemon…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- Apr 22, 2026QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Sugar Free,…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- Apr 22, 2026exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavo…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- Apr 22, 2026QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Vanilla Hone…Drug · Xiamen Kang Zhongyuan Biotechnology Co., Ltd.This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.Class II
- caring mill, Menthol Cough Suppressant Oral Anesthetic, Cough Drops, Cherry, 90-count b…
- QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flav…
- MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 80-c…
- QC Quality Choice, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Cherry Flav…
- Halls Cough Drops a) BAGS, MENTHOL, 12CT
- Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400m…
- Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 m…
- CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per…
- Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag…
- Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag…
- Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per b…
- Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops…
- Premier Value Tussin Cough DM, Dextromethorphan HBr
- Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaife…
- Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4
- Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7
- Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP…
- NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER D…
- CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorph…
- QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 thro…
- ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901…
- ZARBEES NTRL CHLD COUGH MUCUS GRP 4 FL OZ distributed to specific Family Dollar Stores…
- VICKS VAPOCOOL DROPS SEVERE 18 CT SKU 999488 BEST HEALTH HONEY LEMON COUGH DROP 80 CT…
- Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally…
- Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifene…
- CETAFEN COUGH & COLD COUGH & COLD RELIEF (Acetaminophen 325 mg, Dextromethorphan HBr 15…
- Childrens Dimetapp Cold & Cough, For ages 6 yrs
- Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppr…
- Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per carton
- DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single…
- Kid Kare Childrens Cough/Cold Liquid, Antihistamine, Cough Suppressant, Nasal Decongest…
- Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trisp…
- Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per…
- Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectoran…
- Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl
- Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 m…
- Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg),…
- Pedia Relief Cough-Cold Oral Solution, Alcohol free, antihistamine, cough suppressant,…
- CVS Health Children's Cough & Chest Congestion DM Dextromethorphan HBr, 5 mg Cough Supp…
- CVS Health Children's Cough Syrup English Ivy Leaf Daytime Relief Natural Pineapple Fla…
- CVS Health Children's Mucus Relief Chest Congestion Plus Cough Dextromethorphan HBr Cou…
- DrKids Children's Cough & Chest Congestion DM, Dextromethorphan HBr 5 mg Guaifenesin 10…
- DrKids Children's Natural Cough Syrup English Ivy Leaf Organic Agave Nectar Pre-measure…
- Dr. King's Natural Medicine for kids! Children's Cough Relief Homeopathic, 2 fl. oz. (5…
- Dr. King's Natural Medicine Homeopathic Cough Relief, 2 fl. oz. (59 mL), King Bio, Inc.…
- Dr. King's SafeCare Rx Cough Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dri…
- Dr. King's SafeCare Rx Children's Cough Children High Potency Homeopathic Formula for P…
- Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis
- Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephrine hydroch…
- Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid 8 oz
- CVS SUGAR FREE BLACK CHERRY COUGH DROPS (MENTHOL-COUGH SUPPRESSANT), Packaged in a) 25…
- Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Coug…
- Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Stre…
- Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl…
- SUCRETS Sore Throat & Cough Vapor Cherry lozenges, 18-count tin, Dist
- Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorp…
- Children's Triacting Night Time Cold & Cough with PE (diphenhydramine hcl and phenylep…
- Pleo Not CAPSULES 4X, 20 Tablet Cartons, Oral Homeopathic Fever Reducer/ Cough Suppress…
- Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 6…
- Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramin…
- Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and phen…
- Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromi…
- NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochlo…
- Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochlo…
- Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine…
- Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine…
- Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen 650mg, De…
- CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz
- BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decon…
- BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC,…
- Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz
- Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bott…
- ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz
- AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry…
- AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count…
- AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry…
- AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry…
- Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz
- TL-DEX DM, Cough Suppressant Decongestant, Expectorant 16 fl oz
- TL Hist DM, Antihistamine, Decongestant, Cough Suppressant, 16 fl oz
- Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan…
- Rite Aid Maximum Strength Tussin Cough & Cold Mucus Relief CF, (dextromethorphan HBr 10…
- Select Brand Cough Control CF Max, Maximum Strength for MUCUS RELIEF, (dextromethorphan…
- Prometh VC with Codeine Cough Syrup, CV, Each 5mL contains: Codeine phosphate 10mg
Showing the 94 most recent recalls of cough & cold medicine products. 105 FDA reports mention cough & cold medicine in total, including as an ingredient in other products. Use the search on the homepage to look up a specific brand or lot number.
Questions about cough & cold medicine recalls
Is there a cough & cold medicine recall right now?
There are no new FDA cough & cold medicine recall reports in the last 90 days as of October 7, 2026. The most recent was “MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops, Honey Lemon, 30-c…” from Xiamen Kang Zhongyuan Biotechnology Co., Ltd. (Class II), reported Apr 22, 2026. FDA reports can appear weeks after a recall starts, so also check the FDA's official recall notices.
What should I do with a recalled cough & cold medicine product?
If you have a recalled cough & cold medicine product, compare the lot number and expiration date with the recall. Don't stop taking a prescription medicine on your own: call your pharmacist or doctor, who can confirm whether your supply is affected and arrange a replacement. In an emergency, call 911 or Poison Control at 1-800-222-1222.
How do I know if my cough & cold medicine product is part of the recall?
Open the recall in the list on this page and compare the brand, product size, lot or UPC code, and best-by or expiration date with your package. A match on the product name alone doesn't mean your item is affected. You can also search by lot number on the FindMyRecall homepage.
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