Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug

Novartis Consumer Health: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Agency Publication Date: January 17, 2014
Share:
Sign in to monitor this recall

Affected Products

Product: Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UP

Lot #: a) 25777303, 25777304, Exp 5/31/2013; 25777501, 25777502, Exp 6/30/2013; 25777801, 25777802, Exp 7/31/2013; 25777803, 25981801, 25981802, Exp 8/31/2013; 25981803, 26088801, 26088802, Exp 9/30/2013; b) 25596201, 25596202, 25596203, 25596204, 25596205, 25596206, Exp 5/31/2013; 25596207, 25767001, 25767101, 25767102, 25767103, Exp 6/30/2013; 25767002, 25767104, 25767105, 25767106, 25767201, Exp 7/31/2013; 25767202, 25767203, 25767204, 25767205, 25767206, 25981602, 25981603, 25981604, 25981605, Exp 8/31/2013; 25981601, Exp 9/30/2013

Product: Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-co

Lot #: a) 10116014, Exp 6/30/2013; 10122246, Exp 7/31/2013; 10124322, Exp 9/30/2013; 10128122, Exp 11/30/2013; b) 10119852, Exp 7/31/2013; 10122249, Exp 8/31/2013; 10124321, Exp 9/30/2013; 10128118, Exp 11/30/2013; 10128120, Exp 11/30/2013. NeoCitran Cold & Flu: 10115576, Exp 6/30/2013; 10122243, Exp 8/31/2013 and 10124319, Exp 9/30/2013; Theraflu Exthegran 10115579, 10115572, Exp 6/30/2013; 10117549, Exp 8/30/2013.

Product: Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.

Lot #: a) 10116016, Exp 6/30/2013; 10118931, Exp 7/31/2013; 10121950, Exp 8/31/2013; 10122314, 10122316, 10124226, Exp 9/30/2013; 10124377, 10124379, 10125916, 10128112, 10128114, Exp 10/31/2013; b) 25872801, Exp 7/31/2013

Product: Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton

Lot #: 10089568, Exp 5/31/2013; 10093324, 10094745, 10097626, 10097627, Exp 7/31/2013; 10098588, Exp 9/30/2013. NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief : 10093316, Exp 7/31/2013; 10098591, Exp 9/30/2013; 10101027, Exp 10/31/2013; 10102623, Exp 11/30/2013; 10106813, Exp 1/31/2014; 10115844, Exp 6/30/2014; 10124363, Exp 9/30/2014.

Lot Numbers:
10089568
Product: Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.

Lot #: 10116040, Exp 6/30/2013; 10119871, Exp 7/31/2013; 10122275, Exp 9/30/2013.

Lot Numbers:
10116040
Product: Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1.

Lot #: 10115134, Exp 5/31/2013; 10119862, Exp 7/31/2013; 10122276, 10124325, Exp 10/31/2013.

Lot Numbers:
10115134
Product: Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10

Lot #: 1011525, 10115834, Exp 5/31/2013; 10116012, 10116043, 10116045, 10116047, 10116049, 10117462, 10118936 Exp 6/30/2013; 10118683, 10118685, 10118934, 10118938, Exp 7/31/2013; 10122278, 10122280, 1012282, Exp 8/31/2013; 10124331, 10124333, 10124335, 10125908, Exp 9/30/2013; 10125923, 10126909, 10126911, 10127023, 10127026, Exp 10/31/2013. NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief: 10116036, Exp 6/30/2013 and 10122273, Exp 9/30/2013.

Lot Numbers:
1011525
Product: NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a) NeoCitran Extra Strength Nighttime Total 7 Symptom Relief (UPC 0 58478 10063 0) and b) NeoCitran Extra Strength Cough, Cold & Flu (UPC 0 58478 47363 5).

Lot #: a) 10094895, Exp 7/31/2013; 10098586, Exp 9/30/2013; 10104820, Exp 12/31/2013; 10109982, Exp 2/28/2014; 10110876, Exp 3/31/2014; 10114393, Exp 5/31/2014; 10119851, Exp 7/31/2014; 10122313, Exp 9/30/2014; b) 10097661, Exp 8/31/2013; 10099912, Exp 9/30/2013; 10105539, Exp 12/31/2013; 10109980, Exp 2/28/2014; 10114396, Exp 5/31/2014; 10119849, Exp 7/31/2014; 10122312, Exp 9/30/2014.

Product: NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9).

Lot #: a) 10112236, Exp 4/30/2014 and 10122295, Exp 9/30/2014; b) 10093319, Exp 6/30/2013 and 10100417, Exp 9/30/2013.

Product: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1. Also packaged under foreign labels: Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Co

Lot #: 10113888, Exp 5/31/2013; 10118944, Exp 6/30/2013; 10120024, Exp 9/30/2013; 10124381, Exp 10/31/2013. Russia product: 10112623, 10112625, 10112627, 10112629, 10112631, 10112633, Exp 5/31/2013; 10116051, 10116053, 10116055, 10116057, 10116059, 10116061,10117302, 10117304, Exp 7/31/2013; 10119732, 10119735, Exp 9/30/2013; 10124276, 10124281, 10125922, 10126539, 10126540, 10126541, 10126542, 10126543, Exp 10/31/2013; Korea product: 10112969, Exp 5/31/2013; 10116034, Exp 7/31/2013; 10120027, Exp 9/30/2013.

Lot Numbers:
10113888
Product: NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05503 9.

Lot #: 10122293, Exp 8/31/2013.

Lot Numbers:
10122293
Product: NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3. Also packaged under foreign label: Theraflu Daytime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7116-06, UPC 8 806536 0140

Lot #: 10116030, Exp 6/30/2013. Korea product: 10112972, Exp 5/31/2013 and 10116032, Exp 7/31/2013.

Lot Numbers:
10116030
Product: Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico.

Lot #: a) 10119730, Exp 9/30/2013; b) 10115568, 10115570, Exp 6/30/2013; 10119728, Exp 9/30/2013.

Product: Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)

Lot #: Russia product: 10117513,10117515, 10117517, 10117520, 10118676, 10118680, Exp 6/30/2013 and Former Soviet Union product: 10116986, 10116988, Exp 8/31/2013.

Lot Numbers:
Russia

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 65490
Status: Resolved
Manufacturer: Novartis Consumer Health
Manufactured In: United States
Units Affected: 7 products (917,400 cartons; 1,140,564 cartons; 1,202,960 cartons and cards; 868,104 cartons; 292,320 cartons; 398,208 cartons; 3,753,348 cartons)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.