CLASS II Drug recall · Reported 26 Aug 2015 · FDA Enforcement Report
univasc (moexipril HCl) tablets, 7.5 mg recalled by Ucb
Ucb is recalling univasc (moexipril HCl) tablets, 7.5 mg, distributed nationwide in the US. The recall was initiated on 24 Jul 2015 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-1348-2015
- FDA event ID
- 71986
- Recalling firm
- Ucb, Smyrna, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2015
- FDA classified
- 19 Aug 2015
- Reported
- 26 Aug 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 24 Jul 2015 | Recall initiated by company | |
| 19 Aug 2015 | Classified by FDA | +26 days |
| 26 Aug 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Testing: Failed 24 month dissolution testing.
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
univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Testing: Failed 24 month dissolution testing.
Which lots are affected?
Lot #: 98016P1, Expiry: April, 2016
Where was it sold?
U.S. 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 Ucb
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Keppra (levetiracetam) recalled by UcbKeppra | Ucb | Potency & Assay | TN |