CLASS II Drug recall · Reported 21 Aug 2013 · FDA Enforcement Report
Rifadin (rifampin) capsules recalled by Sanofi-Synthelabo
Sanofi-Synthelabo is recalling Rifadin (rifampin) capsules, USP per. The recall was initiated on 26 Feb 2013 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-886-2013
- FDA event ID
- 65954
- Recalling firm
- Sanofi-Synthelabo, Laval
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2013
- FDA classified
- 13 Aug 2013
- Reported
- 21 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 26 Feb 2013 | Recall initiated by company | |
| 13 Aug 2013 | Classified by FDA | +168 days |
| 21 Aug 2013 | Published in enforcement report | +8 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 review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
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
Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887
Where it was distributed
Canada
Questions about this recall
Why was it recalled?
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
Which lots are affected?
Lot # 3099036, Exp 03/2014
Where was it sold?
Canada
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.