CLASS III Drug recall · Reported 24 Mar 2021 · FDA Enforcement Report
Romidepsin Injecton, 5 mg/ (5 mg/mL) recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals U is recalling Romidepsin Injecton, 5 mg/ (5 mg/mL), distributed nationwide in the US. The recall was initiated on 4 Mar 2021 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-0309-2021
- FDA event ID
- 87452
- Recalling firm
- Teva Pharmaceuticals U, Parsippany, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Mar 2021
- FDA classified
- 19 Mar 2021
- Reported
- 24 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 4 Mar 2021 | Recall initiated by company | |
| 19 Mar 2021 | Classified by FDA | +15 days |
| 24 Mar 2021 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
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
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Where it was distributed
Distributed Nationwide in the USA.
Questions about this recall
Is Romidepsin Injecton, 5 mg/ (5 mg/mL) recalled?
Yes. Teva Pharmaceuticals U recalled Romidepsin Injecton, 5 mg/ (5 mg/mL) on 4 Mar 2021. The recall is Class III and its status is Terminated. Recall number D-0309-2021.
Why was it recalled?
Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.
Which lots are affected?
Lot # 31328184C, exp. date 11/2021 Lot # 31327686C, exp. date 08/2021 Lot # 31327685C, exp. date 08/2021
Where was it sold?
Distributed 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 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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