CLASS II Drug recall · Reported 3 Mar 2021 · FDA Enforcement Report
Imatinib Mesylate Tablets 100mg, packaged as a) bottles recalled
Dr. Reddy's Laboratories is recalling Imatinib Mesylate Tablets 100mg, packaged as a) bottles (, distributed nationwide in the US. The recall was initiated on 17 Feb 2021 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-0287-2021
- FDA event ID
- 87339
- Recalling firm
- Dr. Reddy's Laboratories, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2021
- FDA classified
- 24 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cancer Medication
Timeline
| 17 Feb 2021 | Recall initiated by company | |
| 24 Feb 2021 | Classified by FDA | +7 days |
| 3 Mar 2021 | 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
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Made in India.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot #: a) H2000206, Exp 06/22; b) H2000138, Exp 06/22
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 30 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 Dr. Reddy's Laboratories
All 165| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Varenicline Tablets, 1mg recalled by Dr. Reddy's LaboratoriesVarenicline Tartrate | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Succinylcholine Chloride Injection, USP, 200 mg/ (20 mg/mL) recalledSuccinylcholine | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Omeprazole Delayed-release Capsules, USP, 20mg recalledOmeprazole | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS I | Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg recalledLevetiracetam | Dr. Reddy's Laboratories | Labeling Errors | Nationwide |
| Drug | CLASS III | Javygtor (sapropterin dihydrochloride) Tablets 100mg recalledJavygtor | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
Other Imatinib recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Imatinib Mesylate Tablets 100 mg recalled by Shilpa MedicareImatinib Mesylate | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Imatinib Mesylate Tablets 400 mg recalled by Shilpa MedicareImatinib Mesylate | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Imatinib Mesylate Tablet 400 mg recalled by Kroger Specialty Pharmacy | Kroger Specialty Pharmacy | Other | 5 states |