Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported February 5, 2020
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Macleods Pharma Usa Inc recalled Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : … - a low-severity action.
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : … was recalled by Macleods Pharma Usa Inc in February 5, 2020. Reason: Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product. Check the official notice for the remedy. Verify recall #D-0823-2020 with the FDA Drug before acting.
The recall
Macleods Pharma Usa Inc issued this low-severity FDA Drug recall-Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product.
- Low
- severity level
- 11K units
- affected scope
- Class III
- classification
- February 5, 2020
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0823-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0823-2020) was formally reported on February 5, 2020, with the manufacturer initiating the action on January 20, 2020. It is classified under Low severity (Class III), with a current status of Terminated. Macleods Pharma Usa Inc is listed as the recalling firm, operating out of Plainsboro, NJ. Federal records list the affected scope as 10680 units.
The documented reason for this recall is: Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product Distribution data in the federal record shows the product reached: Nationwide within the United States. 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
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.
Affected scope
10680 units
Related Recalls
6
5 from same agency
Product description
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
Reason for recall
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0823-2020 |
| Date reported | February 5, 2020 |
| Date initiated | January 20, 2020 |
| Recalling firm | Macleods Pharma Usa Inc |
| Firm location | Plainsboro, NJ |
| Affected scope | 10680 units |
| Distribution | Nationwide within the United States |
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-0823-2020) 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? ▼
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10. Recalled by Macleods Pharma Usa Inc. Units affected: 10680 units.
Why was this product recalled? ▼
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 5, 2020. Severity: Low. Recall number: D-0823-2020.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0823-2020) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 February 5, 2020. 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.