Marlex Acetaminophen Tablets Recalled for Manufacturing Practice Deviations
Marlex Pharmaceuticals is recalling 28,387 bottles of Acetaminophen Tablets, 500 mg, because the lot was not manufactured under current good manufacturing practices.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations. Per the rubric, this falls under 'Moderate' as it involves a manufacturing violation without reported illnesses or specific high-risk pathogens.
Plain-English summary
Marlex Pharmaceuticals, Inc. is recalling 28,387 bottles of Acetaminophen Tablets, 500 mg, 100-count bottles. The product is identified by Lot # 3213, Exp 12/13, NDC 10135-152-01, and UPC 3 10135 15201 8. The recall is being conducted nationwide.
The recall was initiated because the specific lot of acetaminophen tablets was not manufactured under current good manufacturing practices (CGMP), as noted by a recent inspection of the manufacturing firm. This is an FDA Class II recall, which indicates a violation of CGMP that may cause temporary or medically reversible adverse health consequences.
Consumers who have this product should stop using it and return it to the place of purchase for a refund or contact Marlex Pharmaceuticals, Inc. for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Marlex Pharmaceuticals, Inc.
- Category
- Drug — Tablets
- Hazard
- Affected units
- 28,387
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 3213
- Exp 12/13
Distribution
Distributed nationwide across the United States.
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