Severity
Moderate
ModerateClass IITerminated
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.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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 FDA Drug action (record #D-1150-2022) was formally reported on June 22, 2022, with the manufacturer initiating the action on June 10, 2022. It is classified under Moderate severity (Class II), with a current status of Terminated. Lupin Pharmaceuticals Inc. is listed as the recalling firm, operating out of Baltimore, MD. Federal records list the affected scope as 3,216 bottles.
The documented reason for this recall is: Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study. Distribution data in the federal record shows the product reached: Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide.. Distribution scope 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 - 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 - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
3,216 bottles
Related Recalls
6
0 from same agency
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.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 3,216 bottles.
Why was this product recalled? ▼
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 22, 2022. Severity: Moderate. Recall number: D-1150-2022.
Where was the recalled product distributed? ▼
Distribution: Product was distributed to 10 wholesalers/distributors and one mail order account who may have further distributed the product nationwide..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1150-2022) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
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.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported June 22, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.