FDA Drug Recalls

Recalls / Class II

Class IID-0229-2024

Product

CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.

Brand name
Magnesium Citrate
Generic name
Cvs Magnesium Citrate Oral Solution - Grape
Active ingredient
Magnesium Citrate
Route
Oral
NDC
51316-881
FDA application
M007
Affected lot / code info
Lot A80763; Exp. 11/2025

Why it was recalled

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Recalling firm

Firm
Pharma Nobis LLC
Manufacturer
CVS Pharmacy, Inc.
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
7400 Alumax Rd, N/A, Texarkana, Texas 75501-0282

Distribution

Quantity
13,344 bottles
Distribution pattern
Nationwide.

Timeline

Recall initiated
2023-12-21
FDA classified
2024-01-12
Posted by FDA
2024-01-24
Status
Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-0229-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: Magnesium Citrate · FDA Drug Recalls