Food, drugs, devices › Watson Laboratories Inc

Drug recall: Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laborato

FDA enforcement event 66251 · Class II · initiated 13 Sep 2013 · status Terminated · terminated 25 Jul 2014

DrugVoluntary: Firm initiated1 product recordCorona, CA

FDA enforcement event 66251 is a drug recall by Watson Laboratories Inc of Corona, CA, initiated 13 Sep 2013 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 56% of the 370 drug enforcement events initiated in 2013 carry the same class.

Status: Terminated, terminated 25 Jul 2014. Initiation: voluntary: firm initiated. Watson Laboratories Inc has 13 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Watson Laboratories Inc, Corona, CA.

Reason for recall

"Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-66251-001	Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01	10,615 bottles	Class II	Terminated	9 Oct 2013

Context

56%of 2013 drug events are Class II370 events that year

1product record in this eventfirm median: 1

13events on this register for the firm

Other enforcement events for Watson Laboratories Inc

Initiated	Product (first record)	Type	Class	Records
15 Jan 2014	Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by W	Drug	Class II	1
23 Dec 2013	Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Sal	Drug	Class II	1
23 Sep 2013	Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54),	Drug	Class II	1
30 Aug 2013	Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Labor	Drug	Class III	1
19 Jul 2013	Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bo	Drug	Class III	1
13 Feb 2013	ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by	Drug	Class II	1
8 Feb 2013	Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA	Drug	Class II	2
13 Dec 2012	Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15	Drug	Class III	1
19 Oct 2012	Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispens	Drug	Class II	5
21 Sep 2012	Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured	Drug	Class I	1

All 13 events for Watson Laboratories Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 25 Jul 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.