CLASS II Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Major Extra Strength Acetaminophen Tablets recalled
Contract Pharmacal is recalling Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, distributed nationwide in the US. The recall was initiated on 3 Feb 2020 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-0858-2020
- FDA event ID
- 84857
- Recalling firm
- Contract Pharmacal, Hauppauge, NY
- Brand
- Acetaminophen
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Feb 2020
- FDA classified
- 27 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 3 Feb 2020 | Recall initiated by company | |
| 19 Feb 2020 | Published in enforcement report | +16 days |
| 27 Feb 2020 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer, packaged in a) 100-count bottles (NDC 0904-6730-60; UPC 3 09046 73060 6) and b) 1000-count bottles (NDC 0904-6730-80; UPC 3 09046 73080 4) Distributed by Major Pharmaceuticals 17177 N. Laurel Park Drive, Suite 233 Livonia, MI 45162 USA
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement tablet commingled in a bottle of Extra Strength Acetaminophen 500 mg contents 1000 count bottle.
Which lots are affected?
Lot #: 193005, Exp. Date 08/21
Where was it sold?
Nationwide within the United States
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.
Other products in this recall event
1 other product · FDA event 84857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Leader Extra Strength Acetaminophen Tablets recalled | Contract Pharmacal | Other | Nationwide |
More recalls from Contract Pharmacal
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Extra Strength Acetaminophen recalled by Contract PharmacalAcetaminophen | Contract Pharmacal | Other | MI |
| Drug | CLASS II | Leader Extra Strength Acetaminophen Tablets recalled | Contract Pharmacal | Other | Nationwide |
Other Acetaminophen recalls
All 63| 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 |