CLASS III Drug recall · Reported 25 Jul 2012 · FDA Enforcement Report
Pitocin (Oxytocin Injection, USP) Synthetic per mL recalled
JHP Pharmaceuticals is recalling Pitocin (Oxytocin Injection, USP) Synthetic per mL, distributed nationwide in the US. The recall was initiated on 5 Jun 2012 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-1420-2012
- FDA event ID
- 62013
- Recalling firm
- JHP Pharmaceuticals, Rochester, MI
- Brand
- Pitocin
- Manufacturer
- Par Health USA, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Jun 2012
- FDA classified
- 16 Jul 2012
- Reported
- 25 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Jun 2012 | Recall initiated by company | |
| 16 Jul 2012 | Classified by FDA | +41 days |
| 25 Jul 2012 | 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
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Which lots are affected?
Lot 231423, 255867
Where was it sold?
Nationwide and Puerto Rico
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.
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 |