Browse Drug Recalls
18,041 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,041 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 18,041 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| Dec 17, 2019 | Stallion Platinum 30000 Capsules in blue,orange,white background with red,whi... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Panther Platinum 30000 Capsules, in green, black background with white, red t... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: G... | 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. |
| 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 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background wi... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Gl... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Class II | Hikma Pharmaceuticals USA Inc. |
| Dec 17, 2019 | Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,whi... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 16, 2019 | NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 ... | Subpotent Drug | Class III | Pharmedium Services, LLC |
| Dec 16, 2019 | NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 ... | Subpotent Drug | Class III | Pharmedium Services, LLC |
| Dec 16, 2019 | Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx o... | Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of th... | Class II | Akorn Inc |
| Dec 16, 2019 | NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 ... | Subpotent Drug | Class III | Pharmedium Services, LLC |
| Dec 13, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Class III | The Harvard Drug Group |
| Dec 13, 2019 | RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA ND... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Granules India Limited |
| Dec 13, 2019 | Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx... | Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other i... | Class III | Lupin Pharmaceuticals Inc. |
| Dec 11, 2019 | Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repac... | CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts a... | Class II | RemedyRepack Inc. |
| Dec 11, 2019 | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronize... | Subpotent Drug: Supplier indicated assay results did not meet specifications. | Class II | Spectrum Laboratory Products |
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.