Drug recall: Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only…

Class III FDA enforcement event 64643. Recall start date: 15 Mar 2013. Status in the FDA record: Terminated. Termination date: 15 Jan 2014.

Reason for recall, in the words of FDA

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Teva Pharmaceuticals USA, Inc. started this drug recall on 15 Mar 2013. The firm address in the FDA record is in Sellersville, PA. FDA put the recall in Class III. FDA event 64643 has 2 product records. The first FDA enforcement report date is 17 Jul 2013. The record gives the status Terminated, with the termination date 15 Jan 2014.

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 and Puerto Rico

Recalling firm

Teva Pharmaceuticals USA, Inc., Sellersville, PA.

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 64643: product records
Recall number	Product	Quantity	Class	Status	Report date
D-689-2013	Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58	154,536 cartons	Class III	Terminated	17 Jul 2013
D-690-2013	Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58	59,240 Cartons	Class III	Terminated	17 Jul 2013

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 III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2013: 370
Share of these events in Class III: 26%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 60

Other events of the firm

Other FDA enforcement events of Teva Pharmaceuticals USA, Inc.
Initiated	Product (first record)	Type	Class	Records
24 Aug 2026	traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zag	Drug	Class II	1
24 Apr 2026	Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL	Drug	Class II	1
6 Apr 2026	Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs	Drug	Class II	1
19 Mar 2026	Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufact	Drug	Class II	3
17 Mar 2026	Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx onl	Drug	Class II	3
29 Jan 2026	Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles	Drug	Class II	4
12 Jan 2026	Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc.	Drug	Class II	2
7 Nov 2025	Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavi	Drug	Class III	1
13 Oct 2025	Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx o	Drug	Class II	1
7 Oct 2025	Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194	Drug	Class II	3

Teva Pharmaceuticals USA, Inc.: all 60 events

Official channels

FDA enforcement report D-689-2013The 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 64643. https://recallregister.com/fda/iii/64643/. 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 and Puerto Rico
What quantity of product is in FDA event 64643?: The event has 2 product records. The first record gives this quantity: 154,536 cartons
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2013 have the same class?: 26% of the 370 drug events that started in 2013 are in Class III.