ModerateClass IITerminated

FDA Drug recall · Reported February 22, 2017

Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4

Q: Which agency issued this recall?

This recall was issued by the FDA Drug on February 22, 2017. Severity: Moderate. Recall number: D-0476-2017.

Q: Where was the recalled product distributed?

Distribution: Nationwide in US.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.

Recall #: D-0476-2017
Affected scope: 499320 units
Initiated: January 30, 2017

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Drug →

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Actavis Inc recalled Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Pa… - a moderate-severity action.

Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Pa… was recalled by Actavis Inc in February 22, 2017. Reason: Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour te…. Check the official notice for the remedy. Verify recall #D-0476-2017 with the FDA Drug before acting.

The recall

Actavis Inc issued this moderate-severity FDA Drug recall-Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour te….

Moderate
severity level: 499K units
affected scope: Class II
classification: February 22, 2017
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0476-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4

Reason for recall

Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-0476-2017
Date reported	February 22, 2017
Date initiated	January 30, 2017
Recalling firm	Actavis Inc
Firm location	Parsippany, NJ
Affected scope	499320 units
Distribution	Nationwide in US

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

499320 units units affected - multi-state distribution scale.

Regional (<10K units) -

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) ✓ This recall

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (D-0476-2017) and product description against the item you own. Search the archive
Confirm the current status with FDA Drug before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4. Recalled by Actavis Inc. Units affected: 499320 units.

Why was this product recalled? ▼

Failed Dissolution Specifications. Above out of specification for dissolution rate observed at the 10 hour testing point.

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on February 22, 2017. Severity: Moderate. Recall number: D-0476-2017.

Where was the recalled product distributed? ▼

Distribution: Nationwide in US.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

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Same product category, closest by report date among other firms and states (deduped against the severity set).

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This recall: FDA Drug, reported February 22, 2017. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026