CLASS III Drug recall · Reported 15 Nov 2023 · FDA Enforcement Report
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL recalled
VistaPharm is recalling Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, distributed nationwide in the US. The recall was initiated on 26 Oct 2023 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-0093-2024
- FDA event ID
- 93322
- Recalling firm
- VistaPharm, Largo, FL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Oct 2023
- FDA classified
- 8 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 26 Oct 2023 | Recall initiated by company | |
| 8 Nov 2023 | Classified by FDA | +13 days |
| 15 Nov 2023 | 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
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Product as listed by the FDA
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
Where it was distributed
Nationwide and Saudi Arabia
Questions about this recall
Why was it recalled?
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Which lots are affected?
Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
Where was it sold?
Nationwide and Saudi Arabia
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 1 Oct 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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|---|---|---|---|---|---|
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