Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Aug 8, 2013 (13 years ago)

Acetaminophen Tablets

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

Why it was recalled

CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.

Affected NDC 10135-0152-01

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

Drug: Acetaminophen Category: Pain Relief & OTC Medication

Recalling firm
Marlex Pharmaceuticals, Inc.
NDC code
10135-152-01
Origin
DE, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1064-2013 · 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 Acetaminophen recalls

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Class II · Moderate risk

Tylenol

Defective Container

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

Acetaminophen 500mg Caffeine 65mg caplets

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.

Ongoing Labeling / mix-up Aero Healthcare NDC 55305-135-01 D-0155-2026

Other recalls by Marlex Pharmaceuticals, Inc.

All 2013 recalls
Class II · Moderate risk

Digoxin Tablets

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Terminated Labeling / mix-up Marlex Pharmaceuticals, Inc. NDC 10135-0748-01 D-1170-2023
Class I · High risk

Digoxin Tablets

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

Terminated Labeling / mix-up Marlex Pharmaceuticals, Inc. NDC 10135-0747-01 D-1169-2023