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FDA Drug recall · Reported October 18, 2017

Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01

Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.

Recall #
D-0007-2018
Affected scope
128 bottles
Initiated
September 22, 2017
Verify with FDA Drug →
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Boehringer Ingelheim Pharmaceuticals, Inc. recalled Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehrin… - a low-severity action.

Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehrin… was recalled by Boehringer Ingelheim Pharmaceuticals, Inc. in October 18, 2017. Reason: Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.. Check the official notice for the remedy. Verify recall #D-0007-2018 with the FDA Drug before acting.

The recall

Boehringer Ingelheim Pharmaceuticals, Inc. issued this low-severity FDA Drug recall-Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert..

Low
severity level
Class III
classification
October 18, 2017
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0007-2018 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

0100200300400500600 20052008201120142017202020232026 196
Severity1906864652High severity (most serious)Moderate severityLow severity
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 low severity.

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

Product description

Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01

Reason for recall

Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Low (Class III)
Status Terminated
Recall number D-0007-2018
Date reported October 18, 2017
Date initiated September 22, 2017
Recalling firm Boehringer Ingelheim Pharmaceuticals, Inc.
Firm location Danbury, CT
Affected scope 128 bottles
Distribution CO, OH

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-0007-2018) 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?
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01. Recalled by Boehringer Ingelheim Pharmaceuticals, Inc.. Units affected: 128 bottles.
Why was this product recalled?
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Which agency issued this recall?
This recall was issued by the FDA Drug on October 18, 2017. Severity: Low. Recall number: D-0007-2018.
Where was the recalled product distributed?
Distribution: CO, OH.
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.

Compare this recall with CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per … → · All Children & Baby Products recalls

This recall: FDA Drug, reported October 18, 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