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LowClass IIITerminated

FDA Drug recall · Reported December 26, 2018

Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40

Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.

Recall #
D-0349-2019
Affected scope
5,016 blister packs
Initiated
November 27, 2018
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
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Glenmark Pharmaceuticals Inc., USA recalled Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in In… - a low-severity action.

Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in In… was recalled by Glenmark Pharmaceuticals Inc., USA in December 26, 2018. Reason: Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blis…. Check the official notice for the remedy. Verify recall #D-0349-2019 with the FDA Drug before acting.

The recall

Glenmark Pharmaceuticals Inc., USA issued this low-severity FDA Drug recall-Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blis….

Low
severity level
Class III
classification
December 26, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0349-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Drug action (record #D-0349-2019) was formally reported on December 26, 2018, with the manufacturer initiating the action on November 27, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Glenmark Pharmaceuticals Inc., USA is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 5,016 blister packs.

The documented reason for this recall is: Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack. Distribution data in the federal record shows the product reached: 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, 5 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.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,287 drugs & medications recalls on record

-50005001,0001,5002,000 2006201220152018202120242026 263
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.

Severity

Low

Affected scope

5,016 blister packs

Related Recalls

6

5 from same agency

Product description

Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40

Reason for recall

Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.

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-0349-2019
Date reported December 26, 2018
Date initiated November 27, 2018
Recalling firm Glenmark Pharmaceuticals Inc., USA
Firm location Mahwah, NJ
Affected scope 5,016 blister packs
Distribution 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-0349-2019) 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?
Aprepitant Capsules, USP 40 mg, 1 capsule Unit Blister Pack, Rx Only, Manufactured in India for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430. UPC 368462583401. NDC 68462-583-40. Recalled by Glenmark Pharmaceuticals Inc., USA. Units affected: 5,016 blister packs.
Why was this product recalled?
Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 26, 2018. Severity: Low. Recall number: D-0349-2019.
Where was the recalled product distributed?
Distribution: Nationwide.
How do I check if my product is affected by a recall?
Check the product description and recall number (D-0349-2019) 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 December 26, 2018. 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.