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

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate)

Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.

Terminated Dissolution failure Pfizer Inc. NDC 0046-0975-11 D-631-2013
Class III · Low risk

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate)

Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.

Terminated Dissolution failure Pfizer Inc. NDC 0046-0875-11 D-630-2013
Class III · Low risk

Norpace CR

Failed Dissolution Specification

Terminated Dissolution failure Pfizer Inc NDC 0025-2742-31 D-607-2013
Class III · Low risk

Excedrin

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2062-02 D-744-2014
Class III · Low risk

Theraflu Warming Relief

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-6438-08 D-742-2014
Class III · Low risk

Maximum Strength Comtrex

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2081-24 D-741-2014
Class III · Low risk

Maximum Strength Comtrex

Failed Impurities/Degradation:Specifications:Unknown degradant found during stability testing.

Terminated Impurity / degradation Novartis Consumer Health NDC 0067-2084-24 D-740-2014
Class III · Low risk

Budesonide Capsules

Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.

Terminated Dissolution failure Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-020-03 D-452-2013
Class III · Low risk

Derma-Smoothe/FS

Subpotent Drug: the active ingredient, fluocinolone acetonide, was found to be subpotent during the firm's routine testing.

Terminated Wrong potency / content Hill Dermaceuticals, Inc. NDC 28105-149-04 D-610-2013
Class III · Low risk

Amoxicillin for Oral Suspension

Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

Terminated Failed specification Teva Pharmaceuticals USA, Inc. NDC 0093-4161-78 D-598-2013
Class III · Low risk

Lamisil AT

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

Terminated Labeling / mix-up Novartis Consumer Health NDC 0067-6171-85 D-420-2013
Class III · Low risk

Lisinopril Tablets

Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label

Terminated Labeling / mix-up Aurobindo Pharma USA Inc NDC 65862-041-01 D-498-2013
Class III · Low risk

Bucalsep

Subpotent; Cetylpyridinum Chloride

Terminated Wrong potency / content Hi-Tech Pharmacal Co., Inc. NDC 58552-103-01 D-418-2013
Class III · Low risk

Glenmark Topiramate Tablets

Chemical Contamination: Topiramate Tablets is being recalled due to complaints related to an off - odor. described as moldy, musty or fishy in nature.

Terminated Chemical / undeclared Glenmark Generics Inc., USA NDC 68462-110-60 D-331-2013
Class III · Low risk

Glenmark Pravastatin Sodium Tablets

Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an off-odor described as moldy, musty or fishy in nature.

Terminated Chemical / undeclared Glenmark Generics Inc., USA NDC 68462-197-90 D-330-2013
Class III · Low risk

Glenmark Gabapentin Tablets

Chemical Contamination: Gabapentin Sodium tablets is recalled due to complaints related to an off - odor described as moldy, musty or fishy in nature.

Terminated Chemical / undeclared Glenmark Generics Inc., USA NDC 68462-126-05 D-329-2013

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