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

14,806 recalls, newest first

Class II · Moderate risk

Betamethasone Sodium Phosphate Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-348-2013
Class II · Moderate risk

BET-ACE-LIDO-6-2 Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-347-2013
Class II · Moderate risk

Betamethasone Combination Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-346-2013
Class II · Moderate risk

B-Complex Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-345-2013
Class II · Moderate risk

Bacteriostatic Water for Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-344-2013
Class II · Moderate risk

Betamethasone Acetate and Betamethasone Sodium Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-343-2013
Class II · Moderate risk

Ascorbic Acid Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-342-2013
Class II · Moderate risk

Amikacin Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-341-2013
Class II · Moderate risk

Alpha Lipoic Acid Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-340-2013
Class II · Moderate risk

Acetylcysteine Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-339-2013
Class I · High risk

Affirm XL Nutritional Supplement

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain sulfoaildenafil, an analogue of sildenafil which is an ingredient in an FDA-approved drug for the treatment of male erectile dysfunction, making this an unapproved new drug.

Terminated Chemical / undeclared Affirm XL, Inc. D-015-2014
Class II · Moderate risk

(No Brand) First Aid Kit

CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.

Terminated Stability / shelf life Total Resources Intl D-891-2013
Class II · Moderate risk

Medi-First Brand First Aid Kit

CGMP Deviations: The first aid kits that are subject to the voluntary recall is being initiated due to failure in stability testing of the active ingredient Benzalkonium Chloride.

Terminated Stability / shelf life Total Resources Intl D-890-2013
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
Class II · Moderate risk

Cetacaine Liquid Topical Anesthetic

Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit at the 21 month stability test point.

Terminated Wrong potency / content Cetylite Industries, Inc. NDC 10223-0202-2 D-019-2014
Class II · Moderate risk

Levothroid

cGMP deviations; After quality review of stability failures in previous lots, there is insufficient data to determine that other lots are not affected.

Terminated Stability / shelf life Lloyd Inc. of Iowa NDC 0456-1327-01 D-451-2013

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