CLASS III Drug recall · Reported 22 Jun 2016 · FDA Enforcement Report

Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg recalled

Valeant Pharmaceuticals North America is recalling Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, distributed nationwide in the US. The recall was initiated on 18 Apr 2015 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 13G005P, 13G010P, Exp 06/16; 3H029P, 13J048P, 13J049P, 13J050P, Exp 08/17; 14B047P, 14B048P, 14B049P,14C043P, 14C048P, 14C049P, Exp 01/18; 14D048P, 14D053P, 14D054P, Exp 03/18; 14G042P, 14G047P, 14G049P, Exp 5/18; 14J005P, 14J006P, 14J007P, Exp 07/18; 14K114P, 14K115P, 14K116P, Exp 09/18; 15B008P, 158013P, 15B021P, 15C058P, 15C059P, 15C064P, Exp 01/19; 15E037P, 15E038P, Exp 04/19

Quantity recalled564,454 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-1035-2016
FDA event ID: 70112
Recalling firm: Valeant Pharmaceuticals North America, Bridgewater, NJ
Classification: Class III
Status: Terminated
Recall initiated: 18 Apr 2015
FDA classified: 16 Jun 2016
Reported: 22 Jun 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

18 Apr 2015	Recall initiated by company
16 Jun 2016	Classified by FDA	+425 days
22 Jun 2016	Published in enforcement report	+6 days

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

Reason for recall

Failed Impurities/Degradation Specifications

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

Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 68682-409-10.

Where it was distributed

Nationwide and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications

Which lots are affected?

Lot #: 13G005P, 13G010P, Exp 06/16; 3H029P, 13J048P, 13J049P, 13J050P, Exp 08/17; 14B047P, 14B048P, 14B049P,14C043P, 14C048P, 14C049P, Exp 01/18; 14D048P, 14D053P, 14D054P, Exp 03/18; 14G042P, 14G047P, 14G049P, Exp 5/18; 14J005P, 14J006P, 14J007P, Exp 07/18; 14K114P, 14K115P, 14K116P, Exp 09/18; 15B008P, 158013P, 15B021P, 15C058P, 15C059P, 15C064P, Exp 01/19; 15E037P, 15E038P, Exp 04/19

Where was it sold?

Nationwide and Puerto Rico

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 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

1 other product · FDA event 70112

This product is part of a recall event; the main page for the event is Librax (5 mg chlordiazepoxide HCl recalled.

Reported	Class	Recall	Company	Reason	Where
22 Jun 2016	CLASS III	Librax (5 mg chlordiazepoxide HCl recalledLibrax	Valeant Pharmaceuticals North America	Potency & Assay	Nationwide

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