Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported April 5, 2017
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Hetero USA Inc recalled Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pha… - a low-severity action.
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pha… was recalled by Hetero USA Inc in April 5, 2017. Reason: Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a …. Check the official notice for the remedy. Verify recall #D-0623-2017 with the FDA Drug before acting.
The recall
Hetero USA Inc issued this low-severity FDA Drug recall-Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a ….
- Low
- severity level
- Class III
- classification
- April 5, 2017
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0623-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0623-2017) was formally reported on April 5, 2017, with the manufacturer initiating the action on January 7, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Hetero USA Inc is listed as the recalling firm, operating out of Piscataway, NJ. Federal records list the affected scope as 65,664 bottles.
The documented reason for this recall is: Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle. Distribution data in the federal record shows the product reached: US 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 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
65,664 bottles
Related Recalls
6
0 from same agency
Product description
Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30
Reason for recall
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0623-2017 |
| Date reported | April 5, 2017 |
| Date initiated | January 7, 2017 |
| Recalling firm | Hetero USA Inc |
| Firm location | Piscataway, NJ |
| Affected scope | 65,664 bottles |
| Distribution | US 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-0623-2017) 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 tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30. Recalled by Hetero USA Inc. Units affected: 65,664 bottles.
Why was this product recalled? ▼
Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 5, 2017. Severity: Low. Recall number: D-0623-2017.
Where was the recalled product distributed? ▼
Distribution: US Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0623-2017) 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 April 5, 2017. 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.