CLASS II Drug recall · Reported 22 Apr 2020 · FDA Enforcement Report

Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg recalled

Aurobindo Pharma USA is recalling Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 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

Lot, batch or date codesLot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021

NDC13107-058, 13107-059, 13107-060

UPC0313107058011

Quantity recalled14194 units

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-1229-2020
FDA event ID: 85183
Recalling firm: Aurobindo Pharma USA, East Windsor, NJ
Brand: Acetaminophen And Codeine Phosphate
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/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

Which lots are affected?

Lot #: 058180015A, 058180016A, Exp. Date 07/2021; 05818017B1, Exp. Date 09/2021

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 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

8 other products · FDA event 85183

This product is part of a recall event; the main page for the event is Gabapentin Capsules, USP 100mg recalled by Aurobindo Pharma USA.

Reported	Class	Recall	Company	Reason	Where
22 Apr 2020	CLASS II	Gabapentin Capsules, USP 100mg recalled by Aurobindo Pharma USAGabapentin	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020	CLASS II	Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg recalledAcetaminophen And Codeine Phosphate	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020	CLASS II	Phentermine Hydrochloride Capsules, USP 15mg recalledPhentermine	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020	CLASS II	Levetiracetam Tablets USP 750 mg recalled by Aurobindo Pharma USALevetiracetam	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020	CLASS II	Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg recalledOxycodone And Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020	CLASS II	Mirtazapine Tablets, USP 15mg recalled by Aurobindo Pharma USAMirtazapine	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020	CLASS II	Simvastatin Tablets, USP 40mg recalled by Aurobindo Pharma USASimvastatin	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
22 Apr 2020	CLASS II	Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg recalledAcetaminophen And Codeine Phosphate	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide

More recalls from Aurobindo Pharma USA

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5 Nov 2025Drug	CLASS II	Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength	Kenvue Brands	Other	Nationwide
3 Sep 2025Drug	CLASS II	Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen	Baxter Healthcare	Packaging Defects	Nationwide
25 Jun 2025Drug	CLASS II	Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen	Aurobindo Pharma USA	Manufacturing (CGMP) Deviations	Nationwide
16 Apr 2025Drug	CLASS II	Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
18 Dec 2024Drug	CLASS II	Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion	LNK International	Manufacturing (CGMP) Deviations	Nationwide