Metoprolol Tartrate Injection — Class III drug recall D-0222-2019

Terminated recall by Baxter Healthcare Corporation, reported 2018-11-14, distributed nationwide. Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.

Recall number	`D-0222-2019`
Product type	Drug
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Baxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated	2018-10-15
Classified	2018-11-07
Reported by FDA	2018-11-14
Terminated	2022-08-12
Distributed	Nationwide (US)
Quantity	402,165 vials
NDC	`36000-0033`, `36000-0033-10`
Lot numbers	`A061267`, `A061273`, `A061392`, `A061395`, `A061398`, `A061403`, `A061407`, `A0A0070`, `A0A0073`, `A0A0079`, `A0A0081`, `A0A0083`, `A0A0119`, `A0A0124`, `A0A0125`, `A0A0133`, `A0A0141`, `A0A0145`, `A0A0152`, `A0A0247`, `A0A0252`, `A0A0253`, `A0A0292`, `A0A0293`, `A0A0361`, `A0A0367`, `A0A0390`, `A0A0438`, `A0A0445`, `A0A0453`, `A0A0459`, `A0A0547`, `A0A0551`, `A0A0554`, `A0A0630`, `A0A0631`, `A0A0637`, `A0A0638`, `A0A0777`, `A0A0915` and 6 more
Expiration dates	`2018-10`, `2018-11`, `2018-12`, `2019-01`, `2019-02`, `2019-03`, `2019-04`, `2019-05`, `2019-07`, `2019-08`, `2019-11`

Product

Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10

Reason for recall

Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.

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-0222-2019. 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.