Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported October 3, 2018
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Hetero Labs Limited Unit V recalled Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs L… - a moderate-severity action.
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs L… was recalled by Hetero Labs Limited Unit V in October 3, 2018. Reason: Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.. Check the official notice for the remedy. Verify recall #D-1213-2018 with the FDA Drug before acting.
The recall
Hetero Labs Limited Unit V issued this moderate-severity FDA Drug recall-Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets..
- Moderate
- severity level
- Class II
- classification
- October 3, 2018
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1213-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1213-2018) was formally reported on October 3, 2018, with the manufacturer initiating the action on August 20, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Hetero Labs Limited Unit V is listed as the recalling firm, operating out of Jadcherla Mandal, Mahaboob Nagar. Federal records list the affected scope as 98,016 bottles.
The documented reason for this recall is: Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets. Distribution data in the federal record shows the product reached: Nationwide in the USA. 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 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
98,016 bottles
Related Recalls
6
5 from same agency
Product description
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.
Reason for recall
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1213-2018 |
| Date reported | October 3, 2018 |
| Date initiated | August 20, 2018 |
| Recalling firm | Hetero Labs Limited Unit V |
| Firm location | Jadcherla Mandal, Mahaboob Nagar |
| Affected scope | 98,016 bottles |
| Distribution | Nationwide in the USA |
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-1213-2018) 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? ▼
Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, NDC 31722-726-30.. Recalled by Hetero Labs Limited Unit V. Units affected: 98,016 bottles.
Why was this product recalled? ▼
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 3, 2018. Severity: Moderate. Recall number: D-1213-2018.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1213-2018) 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 October 3, 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.