Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 42961-0112-03 recalled?

Xpect Cold Relief

Yes — this exact package was recalled

1 FDA recall names the code 42961-0112-03 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Acetaminophen Guaifenesein Phenylephrine HCl
Strength
GUAIFENESIN 200 mg/1; ACETAMINOPHEN 325 mg/1; PHENYLEPHRINE…
Form
Tablet · Oral
Labeler
Cintas Corporation
Type
Human OTC Drug
Product code
42961-0112

Recalls naming this package

Class II · Moderate risk

Cold Relief

cGMP deviations

Terminated cGMP deviation Ultra Seal Corporation NDC 42961-112-03 D-0483-2022

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler