CLASS II ONGOING Drug recall · Reported 25 Jun 2025 · FDA Enforcement Report
Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Acetaminophen Tablets, 325 mg, distributed nationwide in the US. The recall was initiated on 22 May 2025 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-0471-2025
- FDA event ID
- 96907
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Manufacturer
- Amazon.com Services LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2025
- FDA classified
- 17 Jun 2025
- Reported
- 25 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 22 May 2025 | Recall initiated by company | |
| 17 Jun 2025 | Classified by FDA | +26 days |
| 25 Jun 2025 | Published in enforcement report | +8 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: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Product as listed by the FDA
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Where it was distributed
USA Nationwide.
Stores named: Amazon
Questions about this recall
Is Acetaminophen Tablets, 325 mg recalled?
Yes. Aurobindo Pharma USA recalled Acetaminophen Tablets, 325 mg on 22 May 2025. The recall is Class II and its status is Ongoing. Recall number D-0471-2025.
Why was it recalled?
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Which lots are affected?
Lot#: AEF124004A, Exp date 08/31/2026
Where was it sold?
USA 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 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 Aurobindo Pharma USA
All 58| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 60mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | 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 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 |
| Drug | CLASS II | Extra Strength Acetaminophen recalled by Contract PharmacalAcetaminophen | Contract Pharmacal | Other | MI |