CLASS II Drug recall · Reported 22 Apr 2020 · FDA Enforcement Report
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg recalled
Aurobindo Pharma USA is recalling Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, distributed nationwide in the US. The recall was initiated on 18 Mar 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-1231-2020
- FDA event ID
- 85183
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Manufacturer
- Aurolife Pharma, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Mar 2020
- FDA classified
- 13 Apr 2020
- Reported
- 22 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 18 Mar 2020 | Recall initiated by company | |
| 13 Apr 2020 | Classified by FDA | +26 days |
| 22 Apr 2020 | Published in enforcement report | +9 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: Products were manufactured in a processing area in which water leakage was observed
Product as listed by the FDA
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg recalled?
Yes. Aurobindo Pharma USA recalled Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg on 18 Mar 2020. The recall is Class II and its status is Terminated. Recall number D-1231-2020.
Why was it recalled?
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Which lots are affected?
Lot #: 060180017A, 060180019B1, 060180020A and 060180021A, Exp. Date 06/2021
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 Aurobindo Pharma USA
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|---|---|---|---|---|---|
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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 |