The Recall Desk
Our severity:HighCPSC·23146·Announced 2023-03-09

Sandoz Recalls Aprepitant Capsules and Lidocaine Prilocaine Cream for Non-Child-Resistant Packaging

Sandoz is recalling Aprepitant 125 mg capsules and Lidocaine and Prilocaine cream because the packaging does not meet child-resistant requirements, posing a poisoning risk to young children if swallowed.

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a high-risk-of-harm product recall where the hazard (poisoning from ingestion by young children) is credible and substantial, but no illnesses or injuries have been reported. The risk is theoretical but addresses a vulnerable population and involves drugs that require child-resistant packaging by law.

Plain-English summary

Sandoz Inc. is recalling approximately 156,750 units of Aprepitant 125 mg capsules and Lidocaine and Prilocaine cream due to failure to meet child-resistant packaging requirements mandated by the Poison Prevention Packaging Act (PPPA). The Aprepitant capsules are sold in non-child-resistant blister cards packaged in cartons; the Lidocaine and Prilocaine cream is packaged in tubes with continuous thread white closures. Both products display warnings indicating "not child-resistant" or "for institutional/hospital use only," but do not have compliant child-resistant packaging.

The recalled products were distributed nationwide through pharmacies as prescribed medications from October 2020 through January 2023. Affected NDC numbers include Aprepitant 0781-2323-68 and 0781-2323-06, and Lidocaine and Prilocaine cream 0168-0357-05, 0168-0357-55, and 0168-0357-56, with multiple lot numbers and expiration dates ranging from February 2023 to April 2024.

If the contents are swallowed by young children, the non-compliant packaging poses a risk of poisoning. No injuries or illnesses have been reported. Consumers should immediately secure the medications out of sight and reach of children and contact Sandoz for a free child-resistant pouch. Once secured, consumers may continue to use the medications as directed.

Consumers can contact Sandoz toll-free at 866-300-2207 (Monday–Friday, 8 a.m. to 5 p.m. ET), email [email protected], or visit www.us.sandoz.com and click on "Product Safety Notices" for more information.

The recalled product

Product
Aprepitant capsules and Lidocaine and Prilocaine cream
Manufacturer
Sandoz Inc., of Princeton, New Jersey (Lidocaine and Prilocaine cream)
Category
Drug — Prescription Medications
Hazard
Affected units
156,750

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · non child resistant packaging

See all →

Similar recalls