Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Pitocin (Oxytocin Injection Recalled by JHP Pharmaceuticals, LLC Due to Labeling: Label Mix-up: Pitocin storage conditions should be...

Date: June 5, 2012
Company: JHP Pharmaceuticals, LLC
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact JHP Pharmaceuticals, LLC directly.

Affected Products

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

Quantity: 26100 vials

Why Was This 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)".

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About JHP Pharmaceuticals, LLC

JHP Pharmaceuticals, LLC has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report