Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported January 29, 2014
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
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Novartis Consumer Health recalled Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochlori… - a moderate-severity action.
Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochlori… was recalled by Novartis Consumer Health in January 29, 2014. Reason: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.. Check the official notice for the remedy. Verify recall #D-756-2014 with the FDA Drug before acting.
The recall
Novartis Consumer Health issued this moderate-severity FDA Drug recall-Presence of Foreign Substance: The products are being recalled because they may contain foreign substances..
- Moderate
- severity level
- Class II
- classification
- January 29, 2014
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-756-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-756-2014) was formally reported on January 29, 2014, with the manufacturer initiating the action on June 18, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Novartis Consumer Health is listed as the recalling firm, operating out of Lincoln, NE. Federal records list the affected scope as 3,753,348 cartons.
The documented reason for this recall is: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Distribution data in the federal record shows the product reached: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
3,753,348 cartons
Related Recalls
6
5 from same agency
Product description
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 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.
Reason for recall
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-756-2014 |
| Date reported | January 29, 2014 |
| Date initiated | June 18, 2013 |
| Recalling firm | Novartis Consumer Health |
| Firm location | Lincoln, NE |
| Affected scope | 3,753,348 cartons |
| Distribution | Nationwide, Mexico, Russia, Korea, Panama, China, and Canada. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-756-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9.. Recalled by Novartis Consumer Health. Units affected: 3,753,348 cartons.
Why was this product recalled? ▼
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 29, 2014. Severity: Moderate. Recall number: D-756-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-756-2014) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 29, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.