Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

1,525 recalls · Class III, newest first

Class III · Low risk

Ritalin HCl

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

Terminated Labeling / mix-up Novartis Pharmaceuticals Corp. NDC 0078-0441-05 D-1228-2014
Class III · Low risk

Ritalin HCl

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

Terminated Labeling / mix-up Novartis Pharmaceuticals Corp. NDC 0078-0440-05 D-1227-2014
Class III · Low risk

Venlafaxine Hydrochloride

Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.

Terminated Dissolution failure McKesson Packaging Services NDC 63739-0512-10 D-1167-2014
Class III · Low risk

Advil PM Caplets

Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

Terminated Wrong potency / content Pfizer Us Pharmaceutical Group NDC 0573-0164-43 D-1166-2014
Class III · Low risk

Nicorette Lozenge

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Terminated Wrong potency / content GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1244-2014
Class III · Low risk

Nicotine polacrilex lozenge

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Terminated Wrong potency / content GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1243-2014
Class III · Low risk

Nicotine polacrilex lozenge

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Terminated Wrong potency / content GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1242-2014
Class III · Low risk

Nicotine polacrilex lozenge

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Terminated Wrong potency / content GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1241-2014
Class III · Low risk

Nicotine polacrilex lozenge

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Terminated Wrong potency / content GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1240-2014
Class III · Low risk

Nicotine polacrilex lozenge

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Terminated Wrong potency / content GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1239-2014
Class III · Low risk

Nicotine polacrilex lozenge

Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

Terminated Wrong potency / content GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline D-1238-2014
Class III · Low risk

Atripla

Presence of Foreign Substance: Red Silicone Rubber Particulates are Present in Drug.

Terminated Particulate / foreign matter Gilead Sciences, Inc. NDC 15584-0101-1 D-1090-2014
Class III · Low risk

Tivicay (dolutegravir)

Cross Contamination with Other Products: Product contains Promacta (eltrombopag).

Terminated Cross-contamination Viiv Healthcare Company NDC 49702-228-13 D-1185-2014

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