Pitocin — Class III drug recall D-1420-2012
Terminated recall by JHP Pharmaceuticals, LLC, reported 2012-07-25, distributed nationwide. Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)
| Recall number | D-1420-2012 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | JHP Pharmaceuticals, LLC, Rochester, MI, United States |
| Recall initiated | 2012-06-05 |
| Classified | 2012-07-16 |
| Reported by FDA | 2012-07-25 |
| Terminated | 2012-11-05 |
| Distributed | Nationwide (US) |
| Quantity | 26,100 vials |
| Reason classes | labeling |
| NDC | 42023-0116, 42023-0116-01, 42023-0116-02, 42023-0116-25 |
| Lot numbers | 231423, 255867 |
Product
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
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)".
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1420-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.