UCB Recalls Univasc Tablets Due to Failed Dissolution Testing
UCB, Inc. is recalling Univasc (moexipril HCl) tablets because they failed 24-month dissolution testing. The recall covers 2,916 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves temporary or medically reversible adverse health consequences. The source text does not report any specific injuries, illnesses, or fatalities, and the hazard is related to failed quality testing rather than a known acute safety event like contamination or mislabeling of a critical allergen.
Plain-English summary
UCB, Inc. is recalling Univasc (moexipril HCl) tablets, 7.5 mg, 100-count bottles. The recall was initiated because the product failed 24-month dissolution testing. This is a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected product is identified by Lot # 98016P1 with an expiration date of April 2016. The NDC number is 0091-3707-01. A total of 2,916 bottles were distributed nationwide in the United States.
Consumers who have this specific lot of Univasc should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product is prescription-only, so patients should consult their prescriber before discontinuing or switching medications.
The recalled product
- Product
- univasc (moexipril HCl) tablets, 7.5 mg, 100 Ct Bottle, Rx Only. Manufactured for UCB, Inc., Smyrna, GA 30080. NDC: 0091-3707-01.
- Manufacturer
- Ucb, Inc
- Category
- Drug — Prescription Medication
- Affected units
- 2,916
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 98016P1
- Expiry: April
- 2016
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Ucb, Inc
See all →- ModerateUCB Recalls Keppra Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2019-07-31
Other drug recalls
- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereCarolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- ModeratePaddock Recalls Moexipril HCl Tablets Due to Dissolution Failure
FDA (Drugs) · 2012-10-17
- LowMcKesson Recalls bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2012-10-10
- SevereTeva Recalls Moexipril Hydrochloride Tablets Due to Impurity Test Failure
FDA (Drugs) · 2018-01-17
- ModerateMcKesson Recalls bupropion Hydrochloride Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2012-10-10
- ModerateUCB Recalls Keppra Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2019-07-31
- ModerateMylan Recalls Capecitabine Tablets Due to Dissolution Failures
FDA (Drugs) · 2015-07-15