Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | BUP 3.5MG/ HYDROM 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... | 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 | CLON 300MCG/MORP 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | FENTANYL 100MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | MORPHINE 6MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | 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 | MORPHINE 4MG/ML INJ in 20mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance In... | 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 |
| 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 | MORPHINE 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | CJC-1295 2000 mcg/Ipamorelin 2000 mcg/mL Inj. in 2 mL vial Assurance Infusio... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BAC 4000MCG /FENT 600MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 5... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BAC 200MCG/ CLONI 250MCG/ MORP 10MG/ML INJ in 20 mL syringe Assurance Infusi... | 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 | 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 | 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 | 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 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 5MG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 30MG/FENT 750MCG/HYDROM 15MG/ML (40) INJ in 20 mL syringe Assurance Infu... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 4MG/FENT 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | MORPHINE 18MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | MORPHINE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 9... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Denton Pharma, Inc. |
| Dec 20, 2019 | SUFENTANIL 150MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | MORP 20MG/SUF 70MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | HCG 1,000U/1ML INJ in 4 mL vial Assurance Infusion (713) 533-8800 | 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 | FENTANYL 3000MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.