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

1,356 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class II · Moderate risk

Clonidine Base Micronized

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Terminated cGMP deviation Gyma Laboratories Of Amer,Inc NDC 12660-0503-01 D-0023-2015
Class II · Moderate risk

Propranolol HCl

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Terminated cGMP deviation Gyma Laboratories Of Amer,Inc D-0022-2015
Class II · Moderate risk

Dipyridamole API

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Terminated cGMP deviation Gyma Laboratories Of Amer,Inc D-0021-2015
Class II · Moderate risk

Cephalexin Capsules

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Terminated cGMP deviation Caraco Pharmaceutical Laboratories, Ltd. NDC 62756-294-88 D-1511-2014
Class II · Moderate risk

Cephalexin Capsules

CGMP Deviations: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.

Terminated cGMP deviation Caraco Pharmaceutical Laboratories, Ltd. NDC 62756-293-88 D-1510-2014
Class II · Moderate risk

METHYLDOPA Tablets USP

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

Terminated cGMP deviation Teva Pharmaceuticals USA NDC 0093-2932-01 D1292-2014
Class II · Moderate risk

INDOMETHACIN Capsules USP

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.

Terminated cGMP deviation Teva Pharmaceuticals USA NDC 0093-4030-01 D-1295-2014
Class II · Moderate risk

INDOMETHACIN Capsules USP

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

Terminated cGMP deviation Teva Pharmaceuticals USA NDC 0093-4029-01 D-1294-2014
Class II · Moderate risk

Metformin Hydrochloride USP

CGMP Deviations: The Active Pharmaceutical Ingredient was not manufactured according to current good manufacturing practices.

Terminated cGMP deviation Betachem, Inc. D-406-2014
Class II · Moderate risk

Lamotrigine Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Terminated cGMP deviation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-866-20 D-0378-2015
Class II · Moderate risk

Ciprofloxacin Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Terminated cGMP deviation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-182-20 D-0377-2015
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-452-20 D-1468-2016
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-451-20 D-1467-2016
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Institutional, Inc. (d.b.a. UDL Laboratories) NDC 51079-450-20 D-1466-2016
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-5210-77 D-66403-012
Class II · Moderate risk

Ciprofloxacin Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-7098-01 D-66403-011
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6900-01 D-66403-010
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6898-01 D-66403-009
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6899-01 D-66403-008
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6897-01 D-66403-007
Class II · Moderate risk

Amlodipine Besylate and Benazepril HCl Capsules

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-6896-01 D-66403-006
Class II · Moderate risk

Amlodipine Besylate Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-5209-77 D-66403-005
Class II · Moderate risk

Ciprofloxacin Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-7097-01 D-66403-004
Class II · Moderate risk

Lamotrigine Tablets

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Terminated cGMP deviation Mylan Pharmaceuticals Inc. NDC 0378-4254-91 D-66403-003

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