Independent register of U.S. FDA drug recalls · updated Oct 14, 2026
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Class II drug recalls - moderate risk

Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.

14,543 recalls, newest first.

Class II · Moderate risk

Thyroid Powder USP

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Terminated cGMP deviation Syntec Pharma Corp D-0014-2019
Class II · Moderate risk

Thyroid Powder USP

CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Terminated cGMP deviation Syntec Pharma Corp D-0013-2019
Class II · Moderate risk

Methyl-Cobalamin injectable

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Terminated Sterility / contamination Auro Pharmacies, Inc. D-1167-2018
Class II · Moderate risk

Folic Acid injectable

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Terminated Sterility / contamination Auro Pharmacies, Inc. D-1166-2018
Class II · Moderate risk

Methyl-Cobalamin injectable

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Terminated Sterility / contamination Auro Pharmacies, Inc. D-1162-2018
Class II · Moderate risk

Methyl-Cobalamin injectable

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Terminated Sterility / contamination Auro Pharmacies, Inc. D-1161-2018
Class II · Moderate risk

Methyl-Cobalamin injectable

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Terminated Sterility / contamination Auro Pharmacies, Inc. D-1160-2018
Class II · Moderate risk

Glutathione injectable

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Terminated Sterility / contamination Auro Pharmacies, Inc. D-1159-2018
Class II · Moderate risk

Dexpanthenol injectable

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Terminated Sterility / contamination Auro Pharmacies, Inc. D-1158-2018
Class II · Moderate risk

Calcium Gluconate injectable

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Terminated Sterility / contamination Auro Pharmacies, Inc. D-1157-2018
Class II · Moderate risk

CoEnzyme-Q10 injectable

Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.

Terminated Sterility / contamination Auro Pharmacies, Inc. D-1156-2018
Class II · Moderate risk

Thyroid Powder 25kg/drum

CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.

Terminated cGMP deviation Sichuan Friendly Pharmaceutical Co.,Ltd. NDC 7807-0170-11 D-0006-2019
Class II · Moderate risk

Montelukast Sodium Tablets

Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.

Terminated Failed specification Hetero Labs Limited Unit V NDC 31722-726-30 D-1213-2018
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1145-2018
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1144-2018
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1143-2018
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1142-2018
Class II · Moderate risk

Amlodipine

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Ongoing Nitrosamine impurity Torrent Pharma Inc. D-1141-2018

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