US Drug Recall Register
Class I · High risk Ongoing Initiated Sep 10, 2012 (14 years ago)

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Superpotent (Multiple Ingredient) Drug: Confirmed customer complaints of oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

What was recalled

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21

Recalling firm
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
NDC code
0603-3888-21
Origin
AL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-057-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Acetaminophen recalls

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Class II · Moderate risk Ongoing

Oxycodone and Acetaminophen CII Tablets USP

Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

SpecGx, LLC NDC 0406-0522-01 D-0255-2026
Class II · Moderate risk Ongoing

Oxycodone and Acetaminophen CII Tablets USP

Reason Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.

SpecGx, LLC NDC 0406-0523-01 D-0254-2026
Class II · Moderate risk Ongoing

Tylenol

Reason Defective Container

Kenvue Brands LLC D-0121-2026
Class II · Moderate risk Ongoing

Acetaminophen 500mg Caffeine 65mg caplets

Reason Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.

Aero Healthcare NDC 55305-135-01 D-0155-2026