CLASS II ONGOING Drug recall · Reported 3 Jul 2024 · FDA Enforcement Report
Extra Strength Acetaminophen recalled by Contract Pharmacal
Contract Pharmacal is recalling Extra Strength Acetaminophen, distributed in Michigan. The recall was initiated on 20 May 2024 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-0566-2024
- FDA event ID
- 94675
- Recalling firm
- Contract Pharmacal, Hauppauge, NY
- Brand
- Acetaminophen
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 May 2024
- FDA classified
- 22 Jun 2024
- Reported
- 3 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 20 May 2024 | Recall initiated by company | |
| 22 Jun 2024 | Classified by FDA | +33 days |
| 3 Jul 2024 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Brownish tablets
Product as listed by the FDA
Extra Strength Acetaminophen 500 MG Tablets,100-count Bottle, Distributed By: MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233, Livonia, MI USA 48152, NDC 0904-6730-60, UPC Number 309046730606
Where it was distributed
MI
Questions about this recall
Is Extra Strength Acetaminophen recalled?
Yes. Contract Pharmacal recalled Extra Strength Acetaminophen on 20 May 2024. The recall is Class II and its status is Ongoing. Recall number D-0566-2024.
Why was it recalled?
Discoloration: Brownish tablets
Which lots are affected?
Lot#: 368638; Exp. 05/2025
Where was it sold?
MI
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 21 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 Contract Pharmacal
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Leader Extra Strength Acetaminophen Tablets recalled | Contract Pharmacal | Other | Nationwide |
| Drug | CLASS II | Major Extra Strength Acetaminophen Tablets recalledAcetaminophen | Contract Pharmacal | Packaging Defects | Nationwide |
Other Acetaminophen recalls
All 46| 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 I | Acetaminophen Injection, 1,000 mg recalled by Hikma Pharmaceuticals USAAcetaminophen | Hikma Pharmaceuticals USA | Packaging Defects | OH, PR |
| Drug | CLASS I | Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen | A-S Medication Solutions | Labeling Errors | Nationwide |