Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 | 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 250MCG/ /FENT 3500MCG/ /MORP 25MG/ML INJ in 20 mL syringe Assurance Infu... | 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 | HYDROMORPHONE 1MG/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 | 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 | 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 | 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 | 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 | MORPHINE 5MG/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 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | PHENOL 2.5% STERILE SOLUTION in 50 mL syringe Assurance Infusion (713) 533-... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | MORPHINE 30MG/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/ CLONI 5MCG/ FENT 200MCG/ SUF 50MCG/ML (40) INJ in 20 mL syringe A... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 17MG/MORP 22MG/ML INJ in 20 mL syringe 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 | HYDROMORPHONE 4MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800 | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | CLON 100MCG/MORP 12MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 40MG/FENT 1200MCG/SUF 400MCG/ML INJ in 20 mL syringe Assurance Infusion ... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 15MG/CLON 400MCG/ FENT 6000MCG/ML INJ in 20 mL syringe Assurance Infusion... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | BUP 20MG/SUF 1000MCG/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 300MCG/FENT 2000MCG/ML INJ in 20 mL syringe Assurance Infusion... | Lack of sterility assurance. | Class II | Assurance Infusion |
| Dec 20, 2019 | Bi-Mix 30 mg/1 mg/mL Inj. in 1 mL vials 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 | 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 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 |
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.