CLASS II Drug recall · Reported 21 Mar 2018 · FDA Enforcement Report
Oxytocin USP, powder-bottle, API American Pharmaceutical Ingredients recalled
American Pharmaceutical Ingredients is recalling Oxytocin USP, powder-bottle, API American Pharmaceutical Ingredients, distributed nationwide in the US. The recall was initiated on 7 Mar 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-0591-2018
- FDA event ID
- 79420
- Recalling firm
- American Pharmaceutical Ingredients, Waterford, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Mar 2018
- FDA classified
- 12 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 7 Mar 2018 | Recall initiated by company | |
| 12 Mar 2018 | Classified by FDA | +5 days |
| 21 Mar 2018 | 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
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
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
Oxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Which lots are affected?
Lot 012517-1R
Where was it sold?
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 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
1 other product · FDA event 79420| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Sermorelin Acetate, powder, a) 1 GM-bottle b) 5 GM-bottle recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
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 | 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 |
| Drug | CLASS II | Fluconazole USP for prescription compounding recalled | American Pharmaceutical Ingredients | Potency & Assay | Nationwide |
Other Oxytocin recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxytocin for Injection, all strengths and presentations recalled | GenoGenix | Sterility | Nationwide |
| Drug | CLASS III | oxyTOCIN/mL) added to 0.9% Sodium Chloride, Injection recalled | QuVa Pharma | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxytocin/mL) in 0.9% Sodium Chloride Injection, USP IV recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Oxytocin/mL) in 0.9% Sodium Chloride Injection recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | oxyTOCIN/mL) added to 0.9% Sodium Chloride Injection for IV Use recalled | QuVa Pharma | Potency & Assay | Nationwide |