CLASS II Drug recall · Reported 6 Aug 2014 · FDA Enforcement Report
Welchol Tablets (colesevelam HCl) 625 mg recalled
Daiichi Sankyo Pharma Development is recalling Welchol Tablets (colesevelam HCl) 625 mg, distributed nationwide in the US. The recall was initiated on 12 Jul 2014 and the FDA has classified it as Class II.
Check your package
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-1505-2014
- FDA event ID
- 68793
- Recalling firm
- Daiichi Sankyo Pharma Development, Edison, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jul 2014
- FDA classified
- 31 Jul 2014
- Reported
- 6 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Temperature Abuse
Timeline
| 12 Jul 2014 | Recall initiated by company | |
| 31 Jul 2014 | Classified by FDA | +19 days |
| 6 Aug 2014 | 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
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Which lots are affected?
Lot NVWG Exp - 11/30/2016
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.
Other products in this recall event
7 other products · FDA event 68793More recalls from Daiichi Sankyo Pharma Development
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg recalled | Daiichi Sankyo Pharma Development | Temperature Abuse | Nationwide |
| Drug | CLASS II | Benicar Tablets (olmesartan medoxomil) 40 mg recalled | Daiichi Sankyo Pharma Development | Temperature Abuse | Nationwide |
| Drug | CLASS II | Benicar Tablets (olmesartan medoxomil) 20 mg recalled | Daiichi Sankyo Pharma Development | Temperature Abuse | Nationwide |
| Drug | CLASS II | Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlo recalled | Daiichi Sankyo Pharma Development | Temperature Abuse | Nationwide |
| Drug | CLASS II | Benicar HCT Tablets (olmesartan recalled by Daiichi Sankyo Pharma | Daiichi Sankyo Pharma Development | Temperature Abuse | Nationwide |