FDA Drug recall · Reported June 22, 2022
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Lupin Pharmaceuticals Inc. recalled Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lu… - a moderate-severity action.
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lu… was recalled by Lupin Pharmaceuticals Inc. in June 22, 2022. Reason: Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during l…. Check the official notice for the remedy. Verify recall #D-1150-2022 with the FDA Drug before acting.
The recall
Lupin Pharmaceuticals Inc. issued this moderate-severity FDA Drug recall-Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during l….
- Moderate
- severity level
- Class II
- classification
- June 22, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1150-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. 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.
Children & Baby Products recalls over time
Where this recall sits in its category - 3,781 children & baby products recalls on record
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
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
Reason for recall
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1150-2022 |
| Date reported | June 22, 2022 |
| Date initiated | June 10, 2022 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Firm location | Baltimore, MD |
| Affected scope | 3,216 bottles |
| Distribution | Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-1150-2022) 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.
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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.
Similar Children & Baby Products · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026