Drug recall: Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc.…

Class II FDA enforcement event 69553. Recall start date: 25 Aug 2014. Status in the FDA record: Terminated. Termination date: 21 Mar 2018.

Reason for recall, in the words of FDA

Subpotent Drug

Class II, in the words of FDA

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

Actavis Inc started this drug recall on 25 Aug 2014. The firm address in the FDA record is in Parsippany, NJ. FDA put the recall in Class II. FDA event 69553 has 2 product records. The first FDA enforcement report date is 5 Nov 2014. The record gives the status Terminated, with the termination date 21 Mar 2018.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide

Recalling firm

Actavis Inc, Parsippany, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 69553: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0232-2015	Vancomycin Hydrochloride Capsule, USP, 125 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3560-15 UPC Code 3-0591356015-4	26,663 cartons	Class II	Terminated	5 Nov 2014
D-0233-2015	Vancomycin Hydrochloride Capsule, USP, 250 mg, 20 count blister pack, Rx Only, Mfd. for: Watson Pharma. Inc. Parsippany, NJ 07054 USA, Mfd. by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45237 USA ---- NDC 0591-3561-15 UPC 3-3-0591356115-1	46,676 cartons	Class II	Terminated	5 Nov 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2014: 313
Share of these events in Class II: 58%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 14

Other events of the firm

Other FDA enforcement events of Actavis Inc
Initiated	Product (first record)	Type	Class	Records
7 Feb 2017	Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx Only, Manufactured by Hi-Tech Pharmacal Co.	Drug	Class III	1
30 Jan 2017	Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinn	Drug	Class II	1
12 Jan 2017	Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL Vials, Rx only, Mfd. for Watson Laboratories In	Drug	Class III	1
2 Aug 2016	Acetasol HC (hydrocortisone and acetic acid otic solution USP) , Rx Only, 10 mL bottle, Manufactured by: Actavis Midatla	Drug	Class III	2
11 Jul 2016	Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg, 90- count bottles, Rx Only Manufactured by: Actavis Elizabet	Drug	Class II	1
30 Jun 2016	Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincin	Drug	Class II	1
4 Jun 2015	Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 2	Drug	Class III	1
12 Feb 2015	Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc.,	Drug	Class II	2
16 May 2014	Vancomycin Hydrochloride Capsules, USP, 250 mg. 20 Capsules on 2 x 10 Capsule Blister Cards, Rx Only. Mfd. for: Watson P	Drug	Class II	1
9 Dec 2013	Trelstar (triptorelin pamoate) for Injectable Suspension Single-Dose Vial (NDC 52544-154-02) plus MIXJECT Single-Dose De	Drug	Class II	1

Actavis Inc: all 14 events

Official channels

FDA enforcement report D-0232-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 69553. https://recallregister.com/fda/ii/69553/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide
What quantity of product is in FDA event 69553?: The event has 2 product records. The first record gives this quantity: 26,663 cartons
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2014 have the same class?: 58% of the 313 drug events that started in 2014 are in Class II.