Browse Drug Recalls
2,151 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,151 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 2,151 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 13, 2015 | Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 13, 2015 | Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) ... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 13, 2015 | Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC ... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 13, 2015 | Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactur... | Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with ... | Class II | GlaxoSmithKline, LLC. |
| Aug 6, 2015 | DuraPrep Surgical Solution Iodine Povacrylex (0.7% Available Iodine) and Isop... | Chemical contamination: Product may be contaminated with a toxic compound. | Class II | 3M Company - Health Care Business |
| Jul 16, 2015 | Felodipine Extended-Release Tablets, 2.5 mg, 100 count bottles, Rx only, Mutu... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutua... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Felodipine Extended-Release Tablets, 5 mg, 100 count bottles, Rx only, Mutu... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Imipramine HCl Tablets, USP, 50 mg, 100 count bottles, Mfd By: Mutual Pharmac... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Imipramine HCl Tablets, USP, 25 mg, 100 count bottles, Mfd By: Mutual Pharmac... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jul 16, 2015 | Imipramine HCl Tablets, USP, 10 mg, 100 count bottles, Rx only, Mfd By: Mutua... | Chemical Contamination; benzophenone leached from the product label varnish | Class III | Mutual Pharmaceutical Company, Inc. |
| Jun 22, 2015 | c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL R... | Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used t... | Class II | Solutions Rx Pharmacy |
| Jun 8, 2015 | TRI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Vaginal Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | METHYLFOLATE Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | HUMAN CHORIONIC GONADOTROPIC (HCG) Injection, Rx, compounded by Life Science ... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Suspensions, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | METHYLFOLATE Injection, Rx, compounded by Life Science Pharmacy Inc., Harrima... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | HUMAN CHORIONIC GONADOTROPIC (HCG) Sublingual Drops, Rx, compounded by Life S... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | E3 CREAM, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Vaginal Creams, Rx, compounded by Life Science Pharmacy Inc., Harrima... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Suppositories, Rx, compounded by Life Science Pharmacy Inc., Harriman... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | TRI-EST Capsules, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | BI-EST Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Face Creams, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | 2-DEOXY-D-GLUCOSE Powder, Rx, compounded by Life Science Pharmacy Inc., Harri... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | ESTRIOL Gels, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | TRI-EST Liquids, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | TRI-EST Lozenges, Rx, compounded by Life Science Pharmacy Inc., Harriman, NY | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Jun 8, 2015 | HYDROXOCOBALAMIN Injection, Rx, compounded by Life Science Pharmacy Inc., Har... | Penicillin Cross Contamination: potentially contaminated with penicillin | Class II | Life Science Pharmacy Inc |
| Apr 30, 2015 | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit, Rx Only, Sodium Sulfacetam... | Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. | Class II | Mission Pharmacal Co |
| Apr 30, 2015 | Sodium Sulfacetamide 9% and Sulfur 4.5% Wash Kit with Sunscreen, Rx Only, Sun... | Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test. | Class II | Mission Pharmacal Co |
| Apr 23, 2015 | Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufa... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvin... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Bi-Est 80:20 Progesterone (estriol,estradiol, progesterone) capsules, Rx only... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufa... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Meloxicam capsules, 12 mg, Rx Only, Manufactured by Park Compounding, Irving,... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable, 10,00... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Methyl Folate Lyophilized Powder for Injection, 20 mg per vial, Rx Only, Manu... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park ... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Leucovorin Calcium capsules, 10 mg, Rx only, Manufactured by Park Compounding... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Artesunate Lyophilized Powder for Injection, 60 mg per vial, Rx only, Manufac... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, ... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) cap... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
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.