CLASS II Drug recall · Reported 3 Oct 2018 · FDA Enforcement Report
Montelukast Sodium Tablets, 10 mg* recalled
Hetero Labs Limited Unit V is recalling Montelukast Sodium Tablets, 10 mg*, distributed nationwide in the US. The recall was initiated on 20 Aug 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1213-2018
- FDA event ID
- 81029
- Recalling firm
- Hetero Labs Limited Unit V, Jadcherla Mandal, Mahaboob Nagar
- Brand
- Montelukast Sodium
- Manufacturer
- Camber Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Aug 2018
- FDA classified
- 26 Sep 2018
- Reported
- 3 Oct 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Inhalers & Asthma Medication
Timeline
| 20 Aug 2018 | Recall initiated by company | |
| 26 Sep 2018 | Classified by FDA | +37 days |
| 3 Oct 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Montelukast Sodium Tablets, 10 mg* recalled?
Yes. Hetero Labs Limited Unit V recalled Montelukast Sodium Tablets, 10 mg* on 20 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-1213-2018.
Why was it recalled?
Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Which lots are affected?
Lot #: MON17355, Exp 12/19
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Hetero Labs Limited Unit V
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium | Hetero Labs Limited (Unit V) | Other | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 50 mg recalled | Hetero Labs Limited (Unit V) | Other | Nationwide |
| Drug | CLASS I | Montelukast Sodium Tablets 10 mg recalled by Hetero Labs Limited Unit VMontelukast Sodium | Hetero Labs Limited Unit V | Packaging Defects | Nationwide |
| Drug | CLASS II | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg recalledValsartan | Hetero Labs Limited Unit V | Potency & Assay | Nationwide |
| Drug | CLASS II | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg recalledValsartan | Hetero Labs Limited Unit V | Potency & Assay | Nationwide |
Other Montelukast recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Montelukast Sodium Tablets, USP 10 mg recalledMontelukast Sodium | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Montelukast Sodium Tablets, USP, 10 mg recalled | Preferred Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Montelukast Sodium Oral Granules USP, 4 mg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Montelukast Sodium Tablets recalled by Direct Rx | Direct Rx | Manufacturing (CGMP) Deviations | Nationwide |