Actavis Recalls Glipizide 2.5 mg Extended-Release Tablets for Dissolution Failure
Actavis Inc is recalling specific lots of Glipizide 2.5 mg Extended-Release tablets because they failed to meet dissolution specifications.
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, and the source text does not report any illnesses, injuries, or fatalities. The hazard is a quality control failure (dissolution) without reported adverse health consequences, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Actavis Inc is recalling 167,152 bottles of Glipizide 2.5 mg Extended-Release tablets, 30-count, Rx Only. The product is manufactured by Patheon Pharmaceuticals Inc in Cincinnati, OH, and carries NDC 00591-0900-30. The affected lots are # 3132593, 3132594, 3134420, 3134421, and 3134422, all with an expiration date of 02/17.
The recall was initiated because the tablets exceeded dissolution specification rates for the 10-hour testing point. This means the medication may not release the active ingredient as intended over time.
The affected products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recall criteria, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, NDC 00591-0900-30
- Manufacturer
- Actavis Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 167,152
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 (6)
- Lot # 3132593
- 3132594
- 3134420
- 3134421
- 3134422
- Exp. 02/17
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Actavis Inc
See all →- ModerateActavis Recalls Levofloxacin Ophthalmic Solution Due to Impurity Failure
FDA (Drugs) · 2017-03-15
- ModerateActavis Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2017-02-22
- LowActavis Recalls Albuterol Sulfate Inhalation Solution Due to Impurities
FDA (Drugs) · 2017-02-01
- LowActavis Recalls Hydrocortisone and Acetic Acid Otic Solution Due to Impurities
FDA (Drugs) · 2016-08-31
- LowActavis Recalls Acetasol HC Otic Solution Due to Impurity Failure
FDA (Drugs) · 2016-08-31
Same hazard · dissolution failure
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateMylan Recalls Acamprosate Calcium Tablets Due to Dissolution Failure
FDA (Drugs) · 2026-08-26
Similar recalls
- ModerateActavis Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2017-02-22
- ModerateGlipiZIDE Extended-Release Tablets 2.5 mg Nationwide Recall
FDA (Drugs) · 2021-10-27
- ModerateAmerican Health Packaging Recalls Glipizide Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2019-05-08
- ModerateAmerisource Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure
FDA (Drugs) · 2017-03-22
- HighFDA recalls glipiZIDE Extended-Release Tablets for failed dissolution specifications
FDA (Drugs) · 2025-01-22
- ModerateActavis Recalls Alprazolam Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2014-03-12