CLASS III Drug recall · Reported 18 Apr 2018 · FDA Enforcement Report
Decitabine for Injection, 50mg per vial recalled
InvaGen Pharmaceuticals is recalling Decitabine for Injection, 50mg per vial, distributed nationwide in the US. The recall was initiated on 5 Mar 2018 and the FDA has classified it as Class III.
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-0698-2018
- FDA event ID
- 79729
- Recalling firm
- InvaGen Pharmaceuticals, Central Islip, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Mar 2018
- FDA classified
- 26 Apr 2018
- Reported
- 18 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Mar 2018 | Recall initiated by company | |
| 18 Apr 2018 | Published in enforcement report | +44 days |
| 26 Apr 2018 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed impurities/degradation specifications: Failure to water content and impurity
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
Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
Where it was distributed
U.S.A. nationwide
Questions about this recall
Is Decitabine for Injection, 50mg per vial recalled?
Yes. InvaGen Pharmaceuticals recalled Decitabine for Injection, 50mg per vial on 5 Mar 2018. The recall is Class III and its status is Terminated. Recall number D-0698-2018.
Why was it recalled?
Failed impurities/degradation specifications: Failure to water content and impurity
Which lots are affected?
Lot #: GE70493, GE70502, GE70512, Exp 8/2019
Where was it sold?
U.S.A. nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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|---|---|---|---|---|---|
| Drug | CLASS I | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets recalledVigabatrin | InvaGen Pharmaceuticals | Packaging Defects | Nationwide |
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Other Decitabine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Decitabine for Injection 50mg per vial recalled | Sun Pharmaceutical Industries | Sterility | Nationwide |