Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on August 08, 2025 and include a total of 16999 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0775-202012-20-2019TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 10 vialsClass IITerminated
D-0687-202012-20-2019BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0677-202012-20-2019Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 15 vialsClass IITerminated
D-0767-202012-20-2019SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0734-202012-20-2019HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 5 vialsClass IITerminated
D-0751-202012-20-2019MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 4 syringesClass IITerminated
D-0727-202012-20-2019FENT 900MCG/SUF 210MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0693-202012-20-2019BUP 20MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0697-202012-20-2019BUP 2MG/ HYDROM 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0672-202012-20-2019BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0768-202012-20-2019SUFENTANIL 300MCG/ML INJ in 20 mL syringe Assurance Infusion (713)-533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0717-202012-20-2019BUP 7MG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0683-202012-20-2019BUP 15MG/CLON 300MCG/ FENT 1500MCG/ML(40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 syringesClass IITerminated
D-0724-202012-20-2019CLON 750MCG/MORP 30MG/SUF 37.5MCG/ML in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0739-202012-20-2019HYDROM 1MG/MORP 20MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0682-202012-20-2019BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0729-202012-20-2019FENTANYL 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0694-202012-20-2019BUP 20MG/SUF 105MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0714-202012-20-2019BUP 5MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0762-202012-20-2019PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 syringesClass IITerminated
D-0721-202012-20-2019CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0704-202012-20-2019BUP 35MG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0723-202012-20-2019CLON 500MCG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0758-202012-20-2019MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 3 syringesClass IITerminated
D-0755-202012-20-2019MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 3 syringesClass IITerminated
D-0710-202012-20-2019BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0756-202012-20-2019MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0764-202012-20-2019QUADMIX 30MG/2MG/20MCG/100MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 190 vialsClass IITerminated
D-0681-202012-20-2019BUP 10MG/HYDROM 10MG/MORP 2MG/SUF 250MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0686-202012-20-2019BUP 15MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0670-202012-20-2019BAC 2400MCG/ FENT 2600MCG/ MORP 3600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0741-202012-20-2019HYDROMORPHONE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0766-202012-20-2019QUADMIX FORTE 30MG/4MG/40MCG/400MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 134 vialsClass IITerminated
D-0748-202012-20-2019IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 5 vialsClass IITerminated
D-0663-202012-20-2019Autologous Serum 20% Eye Drops in 3 mL droppers Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 32 droppersClass IITerminated
D-0719-202012-20-2019BUP 9MG/ HYDROM 25MG/ SUF 110MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0695-202012-20-2019BUP 21MG/CLON 252MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0757-202012-20-2019MORPHINE 30MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 syringesClass IITerminated
D-0745-202012-20-2019HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0709-202012-20-2019BUP 40MG/MORP 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0698-202012-20-2019BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0740-202012-20-2019HYDROMORPHONE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0752-202012-20-2019MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0702-202012-20-2019BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 syringesClass IITerminated
D-0700-202012-20-2019BUP 30MG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0761-202012-20-2019MORPHINE 7MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0679-202012-20-2019BPC-157 2000 mcg/mL in 5 mL vials Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 28 vialsClass IITerminated
D-0731-202012-20-2019FENTANYL 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0708-202012-20-2019BUP 40MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0735-202012-20-2019HCG 10,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 vialsClass IITerminated
D-0685-202012-20-2019BUP 15MG/CLON 600MCG/MORP 30MG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 syringesClass IITerminated
D-0706-202012-20-2019BUP 3 mg/MORP 15 mg/mL Inj. in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0703-202012-20-2019BUP 35MG/FENT 1.5MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0742-202012-20-2019HYDROMORPHONE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0771-202012-20-2019TESTOSTERONE CYP 200MG/ML OIL (SESAME) INJ in 10 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 7 vialsClass IITerminated
D-0705-202012-20-2019BUP 3MG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0746-202012-20-2019HYDROMORPHONE 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0774-202012-20-2019TRIMIX (UA) 30MG/1MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 vialClass IITerminated
D-0713-202012-20-2019BUP 5MG/HYDROM 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0777-202012-20-2019TRIMIX FORTE 4 (UA) 30MG/3MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 10 vialsClass IITerminated
D-0707-202012-20-2019BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0684-202012-20-2019BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0760-202012-20-2019MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0737-202012-20-2019HYDROM 10MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0733-202012-20-2019FENTANYL 800MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0665-202012-20-2019BAC 15MCG/HYDROM 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0749-202012-20-2019LIPO B 25MG/50MG/50MG/1000MCG/ML (10ML VIAL) in 20 mL syringe and 10 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 syringes/1 vialClass IITerminated
D-0770-202012-20-2019TESTOSTERONE CYP 200MG/ML OIL in 10 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 5 vialsClass IITerminated
D-0671-202012-20-2019BAC 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0674-202012-20-2019BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0664-202012-20-2019BAC 150 mcg/BUP 2 mg/Hydrom 15 mg/Morp 20 mg/SUF 650 mcg/mL Inj. in 20 mL syringe Assurance Infusion (713)533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0673-202012-20-2019BAC 400MCG/BUP 20MG/HYDROM 15MG/SUF 1000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0690-202012-20-2019BUP 2.5MG/FENT 25MCG/HYDRO 2MG/MORP 40MG/ML in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0669-202012-20-2019BAC 225MCG/ BUP 4.5MG/ CLON 9MCG/ MORP 3MG/ML ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0776-202012-20-2019TRIMIX FORTE 30MG/2MG/20MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 358 vialsClass IITerminated
D-0763-202012-20-2019QUADMIX in 1 mL vial Assurance Infusion (713)-533-8800Lack of sterility assurance.Assurance Infusion / 5 vialsClass IITerminated
D-0779-202012-20-2019TRIMIX SUPER (A) 30MG/2MG/30MCG/ML INJ in 1 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 45 vialsClass IITerminated
D-0732-202012-20-2019FENTANYL 5MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0747-202012-20-2019HYDROMORPHONE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0678-202012-20-2019Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 5 vialsClass IITerminated
D-0662-202012-20-2019Alprostadil 40 mcg/mL (2 mL vial) Inj. Soln. in 2 mL vials Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 60 vialsClass IITerminated
D-0773-202012-20-2019TRIMIX 30MG/1MG/10MCG/ML INJ in 5 mL/10 mL vials Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1290 vialsClass IITerminated
D-0743-202012-20-2019HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 4 syringesClass IITerminated
D-0691-202012-20-2019BUP 20MG/CLON 250MCG/FENT 7200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0692-202012-20-2019BUP 20MG/CLON 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0696-202012-20-2019BUP 23MG/HYDROM 25MG/SUF 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0772-202012-20-2019TESTOSTERONE CYP 200MG/ML OIL INJ in 10 mL vial Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 166 vialsClass IITerminated
D-0689-202012-20-2019BUP 2.5MG/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 syringeClass IITerminated
D-0725-202012-20-2019CLON 800MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0675-202012-20-2019BAC 800MCG/BUP 6.7MG/CLON 600 MCG/FENT 850MCG/MORP 20MG INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0769-202012-20-2019SUFENTANIL 55.5 MCG/ML IN 18ML INJ in 18 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0676-202012-20-2019BACLOFEN 2000MCG/ML (40) INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 syringesClass IITerminated
D-0701-202012-20-2019BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0738-202012-20-2019HYDROM 17MG/PRIALT 5MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0667-202012-20-2019BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0750-202012-20-2019MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0666-202012-20-2019BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0712-202012-20-2019BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 2 syringesClass IITerminated
D-0730-202012-20-2019FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated
D-0754-202012-20-2019MORPHINE 1MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800Lack of sterility assurance.Assurance Infusion / 1 syringeClass IITerminated