CLASS II Drug recall · Reported 9 Oct 2013 · FDA Enforcement Report
Acetaminophen Tablets, 500 mg recalled by Marlex Pharmaceuticals
Marlex Pharmaceuticals is recalling Acetaminophen Tablets, 500 mg, distributed nationwide in the US. The recall was initiated on 8 Aug 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1064-2013
- FDA event ID
- 65967
- Recalling firm
- Marlex Pharmaceuticals, New Castle, DE
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Aug 2013
- FDA classified
- 27 Sep 2013
- Reported
- 9 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 8 Aug 2013 | Recall initiated by company | |
| 27 Sep 2013 | Classified by FDA | +50 days |
| 9 Oct 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 3213, Exp 12/13
Where was it sold?
Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Marlex Pharmaceuticals
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Digoxin Tablets, USP 0.125mg recalled by Marlex Pharmaceuticals | Marlex Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Digoxin Tablets, USP 0.25mg recalled by Marlex Pharmaceuticals | Marlex Pharmaceuticals | Packaging Defects | Nationwide |
Other Acetaminophen recalls
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |