CLASS II Drug recall · Reported 16 Dec 2020 · FDA Enforcement Report
Imatinib Mesylate Tablets 100 mg recalled by Shilpa Medicare
Shilpa Medicare is recalling Imatinib Mesylate Tablets 100 mg, distributed nationwide in the US. The recall was initiated on 8 Dec 2020 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-0124-2021
- FDA event ID
- 86749
- Recalling firm
- Shilpa Medicare, Polepally, Jadcherla, N/A
- Brand
- Imatinib Mesylate
- Manufacturer
- Armas Pharmaceuticals Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Dec 2020
- FDA classified
- 9 Dec 2020
- Reported
- 16 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Cancer Medication
Timeline
| 8 Dec 2020 | Recall initiated by company | |
| 9 Dec 2020 | Classified by FDA | +1 day |
| 16 Dec 2020 | 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
CGMP Deviations
Product as listed by the FDA
Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot #s: 7S10033B, 7S10033A, 7S10031A, Exp. 02/28/2021.
Where was it sold?
Nationwide in the U.S.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 86749This product is part of a recall event; the main page for the event is Azacitidine for Injection 100 mg/vial, For Subcutaneous recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Azacitidine for Injection 100 mg/vial, For Subcutaneous recalledAzacitidine | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Imatinib Mesylate Tablets 400 mg recalled by Shilpa MedicareImatinib Mesylate | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Azacitidine for Injection 100 mg/vial, For Subcutaneous recalled | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Docetaxel Injection USP 160 mg/ (20 mg/mL) recalled by Shilpa Medicare | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Busulfan Injection 60 mg/ (6 mg/mL) recalled by Shilpa Medicare | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Shilpa Medicare
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pemrydi RTU(pemetrexed injection), 500 mg/ (10 mg/mL) recalledPemrydi Rtu | Shilpa Medicare | Other | Nationwide |
| Drug | CLASS II | Pemrydi RTU (pemetrexed injection), 100 mg/ (10 mg/mL) recalledPemrydi Rtu | Shilpa Medicare | Other | Nationwide |
| Drug | CLASS II | Busulfan Injection 60 mg/ (6 mg/mL) recalled by Shilpa Medicare | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Docetaxel Injection USP 160 mg/ (20 mg/mL) recalled by Shilpa Medicare | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Azacitidine for Injection 100 mg/vial, For Subcutaneous recalled | Shilpa Medicare | Manufacturing (CGMP) Deviations | Nationwide |
Other Imatinib recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Imatinib Mesylate Tablets 100mg, packaged as a) bottles recalled | Dr. Reddy's Laboratories | Potency & Assay | 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 |