CLASS III Drug recall · Reported 7 Oct 2020 · FDA Enforcement Report
Nymalize (nimodipine) oral solution, 60 mg/-Dose Cups recalled
Arbor Pharmaceuticals is recalling Nymalize (nimodipine) oral solution, 60 mg/-Dose Cups and 12 Oral Syringes, 2 inner, distributed nationwide in the US. The recall was initiated on 16 Sep 2020 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-1625-2020
- FDA event ID
- 86392
- Recalling firm
- Arbor Pharmaceuticals, Atlanta, GA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 16 Sep 2020
- FDA classified
- 28 Sep 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 16 Sep 2020 | Recall initiated by company | |
| 28 Sep 2020 | Classified by FDA | +12 days |
| 7 Oct 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
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
Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: 356884 Exp. 11/30/2021
Where was it sold?
Nationwide within the United States
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 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.
More recalls from Arbor Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS III | Testosterone Cypionate Injection, USP, 2000 mg/ Vial, Single-Dose recalledTestosterone Cypionate | Arbor Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS I | Cetylev (acetylcysteine) effervescent tablets recalled | Arbor Pharmaceuticals | Packaging Defects | 14 states |