CLASS II Drug recall · Reported 5 Mar 2014 · FDA Enforcement Report

Clonazepam Tablets, USP 2 mg recalled by Actavis Elizabeth

Actavis Elizabeth is recalling Clonazepam Tablets, USP 2 mg, distributed nationwide in the US. The recall was initiated on 6 Nov 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot 58468552 Exp. 05/15

Quantity recalled13,608 bottles

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-1087-2014
FDA event ID: 67053
Recalling firm: Actavis Elizabeth, Elizabeth, NJ
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2013
FDA classified: 21 Feb 2014
Reported: 5 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Anxiety & Sleep Medication

Timeline

6 Nov 2013	Recall initiated by company
21 Feb 2014	Classified by FDA	+107 days
5 Mar 2014	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Clonazepam Tablets, USP 2 mg 100 tablets Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue, Elizabeth, NJ 0737 USA NDC 0228-3005-11 packaged in White/Round HDPE 75 CC with white/round plastic 33 mm CRC closure shipped in corrugated 75 cc carton (24 bottles/carton)

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Subpotent Drug: During routine stability testing one tablet was found with tablet weight below specification.

Which lots are affected?

lot 58468552 Exp. 05/15

Where was it sold?

Nationwide

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.

More recalls from Actavis Elizabeth

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Other Clonazepam recalls

All 10

Reported	Class	Recall	Company	Reason	Where
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 1 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
15 Jan 2025Drug	CLASS I	Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, C-IV recalledClonazepam	Endo USA	Labeling Errors	Nationwide
7 Aug 2024Drug	CLASS I	Clonazepam Orally Disintegrating Tablets recalledClonazepam	Endo Pharmaceuticals	Labeling Errors	Nationwide