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Use caution Drug recall · FDA · Published February 10, 2016

Robitussin PEAK COLD Recall: Label Mix-Up Hazard

Pfizer recalls Adult Robitussin PEAK COLD DM Liquid due to a label mix-up. Check your bottle's lot number and expiration date for details.

🇺🇸 FDA recall #D-0800-2016DrugRobitussin ›
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Recalling firmPfizer Inc100 North Route 206 · Peapack, NJ 07977
✎ GovInfoNow plain-language explainer

What happened, in plain English

Pfizer Inc. is recalling Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid because of a labeling error where the wrong label was applied to the bottles. The recall affects approximately 63,636 plastic bottles distributed nationwide. Consumers should check their product's lot number and expiration date to see if it is included in this specific batch. Read more at govinfonow.com/recall/43164-robitussin-peak-cold-recall-label-mix-up-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/43164-robitussin-peak-cold-recall-label-mix-up-hazard · Updated October 11, 2026 · FDA enforcement record: FDA #D-0800-2016

Cite this page

“Robitussin PEAK COLD Recall: Label Mix-Up Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43164-robitussin-peak-cold-recall-label-mix-up-hazard. Based on FDA recall #D-0800-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0800-2016%22&limit=1).

Why it’s dangerous

The hazard is a labeling mix-up, which means the label may not accurately reflect the contents or usage instructions of the bottle. This could lead to consumers taking the medication incorrectly or being unaware of what they are actually consuming, potentially causing adverse effects or ineffective treatment.

Who’s affected

Consumers who purchased Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid between the production date and February 10, 2016. Individuals relying on the correct dosage instructions for cough and chest congestion are most at risk due to potential confusion from the mislabeled product.

How to tell if you have this one

Look for an 8 oz. (237 mL) plastic bottle of Adult Robitussin PEAK COLD Cough & Chest Congestion DM Liquid distributed by Pfizer, Madison, NJ. Specifically check for NDC 0031-8736-18, Lot # R29364, and an expiration date of 10/17.

  • Brand
    Robitussin
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Bottle Details

    Verify if your bottle matches NDC 0031-8736-18, Lot # R29364, and Exp. 10/17.

  2. Contact Pfizer for Remedy

    The recall record does not specify a remedy or return process; contact Pfizer directly for further instructions.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 4 months after the firm started it.

1. Firm started the recall: Feb 10, 201612. FDA classified it Class III: Mar 31, 201623. Published in FDA’s Enforcement Report: Apr 6, 201634. FDA terminated the recall: Jun 22, 201642016
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0800-2016 (February 10, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0800-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA