CLASS II Drug recall · Reported 28 Feb 2018 · FDA Enforcement Report
Cyclosporine USP, for prescription compounding recalled
American Pharmaceutical Ingredients is recalling Cyclosporine USP, for prescription compounding, distributed nationwide in the US. The recall was initiated on 9 Feb 2018 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-0482-2018
- FDA event ID
- 79149
- Recalling firm
- American Pharmaceutical Ingredients, Waterford, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2018
- FDA classified
- 22 Feb 2018
- Reported
- 28 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Compounded Drugs
Timeline
| 9 Feb 2018 | Recall initiated by company | |
| 22 Feb 2018 | Classified by FDA | +13 days |
| 28 Feb 2018 | Published in enforcement report | +6 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: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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
Cyclosporine USP, for prescription compounding, packaged in a) 5g (NDC 58597-8210-2); b) 10g (NDC 58597-8210-3); c) 100g, NDC 58597-8210-6; d) 500g (NDC 58597-8210-7), RX only, packed by American Pharmaceutical Ingredients, LLC 6650 Highland Road, Waterford, MI 48327
Where it was distributed
Nationwide within USA.
Questions about this recall
Why was it recalled?
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Which lots are affected?
Lot #: a) 062515-2, Exp. 02/28/2019; b) 062515-1, Exp. 02/28/2019; 062515-2, Exp. 02/28/2019; 052317B-2, Exp. 01/31/2021; c) 052317B-1, Exp. 01/31/2021; 052317B-1, Exp. 01/31/2021; 062515-1, exp. 02/28/2019; d) 052317B-1, Exp. 01/31/2021; 062515-3, exp. 02/28/2019.
Where was it sold?
Nationwide within 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 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
65 other products · FDA event 79149This product is part of a recall event; the main page for the event is Nifedipine USP for prescription compounding recalled.
More recalls from American Pharmaceutical Ingredients
All 71| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sermorelin Acetate, powder, a) 1 GM-bottle b) 5 GM-bottle recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxytocin USP, powder-bottle, API American Pharmaceutical Ingredients recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Levocetirizine Dihydrochloride for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Itraconazole USP (Micronized) for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
| Drug | CLASS II | Ascorbic Acid USP, for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
Other Cyclosporine recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) recalledCequa | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS III | Cequa (cyclosporine ophthalmic solution) 0.09%-Use Vials recalledCequa | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |