Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90…
Reason Subpotent Drug: Subpotent atorvastatin.
Is Amlodipine recalled?
95 FDA recalls mention Amlodipine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amlodipine.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's…
Reason Subpotent Drug: Subpotent atorvastatin.
Class II · Moderate risk Terminated
Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68084-498-11); 10 blister packs per carton (NDC…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/40mg packaged in a)30-count bottle (NDC 43598-316-30), b) 90-count…
Reason Subpotent drug
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/40mg, 90-count bottle, Rx Only Manufactured by Dr. Reddy's…
Reason Subpotent drug
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 10mg/10mg, packaged in a)30-count bottle (NDC 43598-321-30), b) 90-count…
Reason Subpotent drug
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-count…
Reason Subpotent drug
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST…
Reason Failed tablet specifications: One lot was found to contain oversized tablets.
Class II · Moderate risk Terminated
Amlodipine besylate active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class II · Moderate risk Terminated
Amlodipine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Class III · Low risk Terminated
Amlodipine Besylate Tablets, USP 10 mg, Rx Only, 90 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India…
Reason Discoloration: Brown spots were noted embedded in Amlodipine Besylate Tablets, 10 mg, Lot # MP4344.
Class II · Moderate risk Terminated
Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only…
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk Terminated
Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo…
Reason Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b)…
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b)…
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and…
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
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