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Browse Drug Recalls

942 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 942 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 942 FDA drug recalls in TX.

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DateProductReasonClassFirm
Dec 20, 2019 HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 10MG/ FENT 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial... Lack of sterility assurance. Class II Assurance Infusion
Dec 18, 2019 Liothyronine (T3) 80 mcg SR cap Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 T3/T4 SR 9 mcg/38 mcg capsule Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Tadalafil 20 mg Troche Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 DHEA/Pregnenol One 10.25 MG Cap Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Liothyronine (T3) 92.5 MCG Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Progesterone 50 mg capsules Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Sildenafil 200 mg Troche (Clinic) Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Magic Bullet Supplement Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Finasteride/Biotin 1 mg/50 mcg Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Testosterone Topical Cream 4% Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Progesterone E4M SR 100 mg capsules Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Sildenafil 80 mg capsules Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Lidocaine/Priloc/PE 15/5/0.25% 30 GM jars Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Naltrexone 4.5 mg capsule Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Tadalafil 6 mg Capsule Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Progesterone 200 mg Troche Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 18, 2019 Squaric Acid 0.1% Topical Solution (Clinic) 30 mL Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... Class II MPRX, Inc. dba Medical Park Pharmacy
Dec 17, 2019 Panther Platinum 30000 Capsules, in green, black background with white, red t... Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil Class I Motto International Corp
Dec 17, 2019 Stallion Platinum 30000 Capsules in blue,orange,white background with red,whi... Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil Class I Motto International Corp
Dec 17, 2019 Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,whi... Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil Class I Motto International Corp
Dec 17, 2019 Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background wi... Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil Class I Motto International Corp
Nov 20, 2019 SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 SURE 48hr Confidence Nourishing Coconut invisible solid Antiperspirant & Deod... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net W... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 20, 2019 SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant, ... Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient... Class III Idelle Labs
Nov 12, 2019 fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuV... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.2% 400 mg/200 mL (2 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 500 mcg/250 mL (2 mcg/mL) ROPivacaine HCl 0.2% 500 mg/250 mL (2 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL in 35 mL Syringe Preservative Free,... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride 100 mL CADD Pres... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 100 mcg/2 mL (50 mcg/mL) Preservative Free, Rx, QuVA Pharma 1075 W... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 2500 mcg/250 mL (10 mcg/mL) in 0.9% Sodium Chloride 250 mL Bag Prese... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 250 mcg/5 mL (50 mcg/mL), 5 mL Syringe, Preservative Free, Rx, QuVA... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 1000 mcg/20 mL (50 mcg/mL) 20 mL in 20 mL Syringe Preservative Free,... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.125% 125 mg/100 mL (1.25... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 1000 mcg/100 mL (10 mcg/mL) in 0.9% Sodium Chloride Preservative Fre... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 500 mcg/250 mL (2 mcg/mL) 0.125% BUPivacaine HCl 312.5 mg/250 mL (1.... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 400 mcg/200 mL (2 mcg/mL) 0.1% ROPivacaine HCl 200 mg/200 mL (1 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 200 mcg/100 mL (2 mcg/mL) BUPivacaine HCl 0.1% 100 mg/100 mL (1 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 400 mcg/200 mL (2 mcg/mL) ROPivacaine HCl 0.1% 200 mg/200 mL (1 mg/m... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.
Nov 12, 2019 fentaNYL 550 mcg/55 mL (10 mcg/mL) in 0.9% Sodium Chloride 55 mL Syringe Pres... Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... Class II QuVa Pharma, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.