Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 7, 2015 | PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflow... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PGE 25mcg/ml, Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflow... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PHENTO (30mg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B & B Health M... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PHENTO (15mg/0.8333mg/ml) Injection, 5 mL vial, Rx, B & B Health Mart Ph... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | Testosterone prop. 200 mg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pha... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | Testosterone Cypionate 250 mg/mL Injection, 10 mL vial, Rx, B & B Health Mart... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PGE 20mcg/ml Injection, 10 mL vial, Rx, B & B Health Mart Pharmacy, Bellflowe... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (22.5mg/8.33mcg/0.833mg/ml) Injection, 10 mL vial, Rx, B & B... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | Stanozolol 200 mg/ml Injection, 20 mL vial, Rx, B & B Health Mart Pharmacy, B... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA+PGE1+PHENTO (30mg/20mcg/1mg/ml) Injection, 5 mL and 10 mL vials, Rx, B &... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 6, 2015 | TRI-MIX 20MCG+0.5MG+15MG/ML, 10 mL vial, Rx only, Park Compounding Pharmacy 2... | Lack of Assurance of Sterility: all sterile compounded products within expiry | Class II | Chen Shwezin, Inc. dba Park Compounding Pharmacy |
| Oct 6, 2015 | METHYLCOBALAMIN 1000MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280... | Lack of Assurance of Sterility: all sterile compounded products within expiry | Class II | Chen Shwezin, Inc. dba Park Compounding Pharmacy |
| Oct 6, 2015 | CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Ph... | Lack of Assurance of Sterility: all sterile compounded products within expiry | Class II | Chen Shwezin, Inc. dba Park Compounding Pharmacy |
| Oct 6, 2015 | PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 2... | Lack of Assurance of Sterility: all sterile compounded products within expiry | Class II | Chen Shwezin, Inc. dba Park Compounding Pharmacy |
| Oct 6, 2015 | TRI-MIX 10MCG+0.5MG+15MG/ML,5 mL vial, Rx only, Park Compounding Pharmacy 280... | Lack of Assurance of Sterility: all sterile compounded products within expiry | Class II | Chen Shwezin, Inc. dba Park Compounding Pharmacy |
| Sep 23, 2015 | Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Inje... | Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being com... | Class II | Diabetes Corporation of America dba DCA Pharmacy |
| Sep 22, 2015 | P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, ... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | Acetylcysteine 10% Opthalmic Solution, Bedford Pharmacy, 209 Route 101, Bedfo... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Rou... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharm... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharm... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedfor... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 ... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedfo... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 22, 2015 | P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, N... | Lack of assurance of sterility | Class II | Bedford Pharmacy |
| Sep 18, 2015 | Dextrose-NaCl (D5-1/2NS) in NS, Packaged in a) 1700ML Homepumps, b) 1800ML H... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | Lactated Ringers, Packaged in a) 1500ML Homepumps, b) 2800ML Homepumps, and c... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | HYDROMORPHONE HCL, Packaged as a) 2.5MG in 1ML Syringes, b) 150MG in 75ML Hom... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | Dextrose-5% Lactated Ringers, Packaged in 3000ML Homepumps, Rx Only. SENTARA ... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | CLINDAMYCIN 120MG in NS, Package in 20ML Homepumps, Rx Only. SENTARA HOME HEA... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | AZACTAM (aztreonam) 2GM in NS, Packaged in 100ML Homepumps, Rx Only. SENTARA ... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | CEFAZOLIN, Packaged as a) 625MG in 6.2ML Syringes, b) 2GM in 20ML Syringes, c... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | Milrinone in 0.45% NS, Packaged as a) 52MG in 65ML Homepumps, b) 80MG in 100M... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | ASCORBIC ACID 500MG/Syringe, Packaged in 1ML Syringes, Rx Only. SENTARA HOME ... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | PENICILLIN in D5W, Packaged as a)36MU in 360ML Homepumps and b) 51MU in 510ML... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | Invanz (ertapenem) Injection Recon Soln in NS, Packaged as a) 500MG in 50ML H... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | Solu-Cortef (hydrocortisone) 1MG in NS, Packaged in 0.1ML Syringe, Rx Only. S... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | Nafcillin 2GM in NS, Packaged in 50ML Homepumps, Rx Only. SENTARA HOME HEALTH... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 48... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
| Sep 18, 2015 | Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTAR... | Lack of Assurance of Sterility: Product sterility cannot be guaranteed. | Class II | Sentara Enterprises |
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.