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Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

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DateProductReasonClassFirm
Dec 20, 2019 BAC 200MCG/BUP22MG/CLON210MCG/HYDROM 15MG/SUF800MCG/ML ML INJ in 20 mL syring... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) ... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (71... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infu... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syring... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 53... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (7... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion ... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (7... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HCG 3000U/1ML INJ in 4 mL vial Assurance Infusion (713)533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 2... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Denton Pharma, Inc.
Dec 20, 2019 BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 5.3MG/ FENT 1050 MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 5... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance I... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (... Lack of sterility assurance. Class II Assurance Infusion
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 Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro P... Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. Class I Taro Pharmaceuticals U.S.A., Inc.
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 Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Gl... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Glenmark Pharmaceuticals Inc., USA
Dec 17, 2019 Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose ... Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) Class I Hikma Pharmaceuticals USA 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.