Browse Drug Recalls
2,138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,138 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 2,138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Apr 23, 2015 | Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Comp... | Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin. | Class II | South Coast Specialty Compounding, Inc. |
| Apr 23, 2015 | 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 13, 2015 | Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-6... | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ... | Class II | Teva Pharmaceuticals USA |
| Apr 13, 2015 | Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured b... | Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity ... | Class II | Teva Pharmaceuticals USA |
| Mar 10, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PR... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
| Mar 10, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : P... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
| Mar 10, 2015 | BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PR... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
| Mar 10, 2015 | TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3))... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
| Mar 10, 2015 | ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) ... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
| Mar 10, 2015 | BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
| Mar 10, 2015 | BIEST TD 89/11 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) W/V ... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
| Mar 10, 2015 | BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PR... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
| Mar 10, 2015 | BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/... | Recalled products were made using an active ingredient that was recalled by a supplier due to pen... | Class II | the Compounder |
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.