Winder Laboratories, LLC FDA Recalls

3 recalls on file across drugs, food, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Class IIINov 26, 2025Correct Labeled Product Mispack-Size stated on carton label	Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton	Class IIIDrugs	Nov 26, 2025
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDClass IIIOct 27, 2025Subpotent. During an FDA inspection it was discovered that t	Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.	Class IIIFood	Oct 27, 2025
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 PatrClass IIMay 28, 2024Product Mix Up. A bottle of Phenazopyridine HCl tablets USP	Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.	Class IIDrugs	May 28, 2024