Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
Class II · Moderate risk Terminated Initiated Jun 16, 2020 (6 years ago)

Childrens Dimetapp Cold & Cough

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.

Cause type: Packaging defect

Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.

What was recalled

Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.

Affected NDC 0031-2234-19

Compare with the code on your package — it is the most precise check available.

Recalling firm
Glaxosmithkline Consumer Healthcare Holdings
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1362-2020 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Glaxosmithkline Consumer Healthcare Holdings

All 2020 recalls
Class I · High risk

Advil Liqui Gels

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings DBA Haleon D-0183-2023
Class I · High risk

Advil Liqui Gels

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings DBA Haleon D-0182-2023
Class I · High risk

Advil (ibuprofen)

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Terminated Labeling / mix-up Glaxosmithkline Consumer Healthcare Holdings DBA Haleon D-0181-2023
Class II · Moderate risk

TUMS Antacid

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Completed Particulate / foreign matter GlaxoSmithKline Consumer Healthcare Holdings LLC D-0079-2024

Other packaging defect recalls from 2020

All packaging defect recalls
Class II · Moderate risk

Levetiracetam Oral Solution

Defective container: Customer complaints for oral solution leaking from bottles.

Terminated Packaging defect Akorn, Inc. NDC 50383-241-16 D-0221-2021
Class III · Low risk

Desflurane

DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.

Terminated Packaging defect eVenus Pharmaceutical Laboratories NDC 0781-6172-22 D-0042-2021