Chlordiazepoxide HCl/Clidinium Bromide capsules — Class III drug recall D-1035-2016
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2016-06-22, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-1035-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2015-04-18 |
| Classified | 2016-06-16 |
| Reported by FDA | 2016-06-22 |
| Terminated | 2017-06-13 |
| Distributed | Nationwide (US) |
| Quantity | 564,454 bottles |
| Reason classes | specification failure |
| NDC | 68682-0409-10 |
| Lot numbers | 01/18, 01/19, 03/18, 04/19, 06/16, 07/18, 08/17, 09/18, 13G005P, 13G010P, 13J048P, 13J049P, 13J050P, 14B047P, 14B048P, 14B049P, 14C043P, 14C048P, 14C049P, 14D048P, 14D053P, 14D054P, 14G042P, 14G047P, 14G049P, 14J005P, 14J006P, 14J007P, 14K114P, 14K115P, 14K116P, 158013P, 15B008P, 15B021P, 15C058P, 15C059P, 15C064P, 15E037P, 15E038P, 3H029P and 1 more |
Product
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.
Reason for recall
Failed Impurities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1035-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.