CLASS II Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Leader Extra Strength Acetaminophen Tablets recalled
Contract Pharmacal is recalling Leader 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-0857-2020
- FDA event ID
- 84857
- Recalling firm
- Contract Pharmacal, Hauppauge, NY
- 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
- Other Reasons
- 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.
Product as listed by the FDA
Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer,100-count bottles,Distributed by Cardinal Health, Dublin OHIO 43017 NDC 7000-0036-1, UPC 0 96295 13807 8
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer recalled?
Yes. Contract Pharmacal recalled Leader Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reducer on 3 Feb 2020. The recall is Class II and its status is Terminated. Recall number D-0857-2020.
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 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 | Extra Strength Acetaminophen recalled by Contract PharmacalAcetaminophen | Contract Pharmacal | Other | MI |
| Drug | CLASS II | Major Extra Strength Acetaminophen Tablets recalledAcetaminophen | Contract Pharmacal | Packaging Defects | Nationwide |