FDA Drug Recalls
1,525 recalls · Class III, newest first
Mar 3, 2014
Class III · Low risk
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Mar 3, 2014
Class III · Low risk
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
Mar 3, 2014
Class III · Low risk
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Feb 26, 2014
Class III · Low risk
Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 20, 2014
Class III · Low risk
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
Feb 19, 2014
Class III · Low risk
Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.
Feb 11, 2014
Class III · Low risk
Failed Impurity/Degradation Specification; for 17-BMP at the 9 and 18 month stability time point
Feb 11, 2014
Class III · Low risk
Cross Contamination with Other Products: Product contains Promacta (eltrombopag).
Feb 10, 2014
Class III · Low risk
Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014.
Feb 7, 2014
Class III · Low risk
Subpotent Drug: Drug potency was compromised during shipment.
Feb 4, 2014
Class III · Low risk
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Jan 31, 2014
Class III · Low risk
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Jan 31, 2014
Class III · Low risk
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Jan 31, 2014
Class III · Low risk
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Jan 31, 2014
Class III · Low risk
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.
Jan 31, 2014
Class III · Low risk
Subpotent Drug: The active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.