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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 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 6,220 FDA drug recalls.

Clear
DateProductReasonClassFirm
Dec 20, 2019 TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-... 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 TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Inf... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (... 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 BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 53... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syr... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 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 SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800 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 TRIMIX FORTE PLUS 30MG/4MG/40MCG/ML INJ in 1 mL vial Assurance Infusion (713)... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 5... 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 7MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 3MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusi... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 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 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 FENT 600MCG/ SUF 800MCG/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 20, 2019 Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 QUADMIX FORTE in 1 mL vial Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 30MG/ FENT 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
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 BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assuranc... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-... 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 HYDROMORPHONE 5MG/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 MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 BPC-157 2000 mcg/mL in 5 mL vials 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 TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 53... 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 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 CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533... Lack of sterility assurance. Class II Assurance Infusion
Dec 20, 2019 HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 Lack of sterility assurance. Class II Assurance Infusion

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.