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

966 recalls · Class II, newest first

Class II · Moderate risk

Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles

Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.

Terminated Failed specification Inventia Healthcare Private Limited NDC 69097-298-02 D-0224-2017
Class II · Moderate risk

Succinylcholine Chloride

Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.

Terminated Sterility / contamination Pharmedium Services, LLC NDC 61553-0364-65 D-0125-2017
Class II · Moderate risk

DIPYRIDAMOLE Tablets USP

Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.

Terminated Particulate / foreign matter Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0054-0436-25 D-0114-2017
Class II · Moderate risk

Persantine

Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.

Terminated Particulate / foreign matter Boehringer Ingelheim Pharmaceuticals, Inc. NDC 0597-0019-01 D-0113-2017
Class II · Moderate risk

Phenobarbital Tablets

Failed Dissolution Specifications: Phenobarbital Tablets have an out of specification for dissolution at the 12 month stability time point

Terminated Dissolution failure West-Ward Pharmaceuticals Corp. NDC 0143-1455-01 D-1045-2017
Class II · Moderate risk

PredniSONE Tablets USP

Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.

Terminated Failed specification West-Ward Pharmaceutical NDC 0054-4741-25 D-0008-2017

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