Browse Drug Recalls

25 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 25 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 25 FDA drug recalls.

Clear
DateProductReasonClassFirm
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-20 MCG/ML* INJECTABLE, 5 ml, Professio... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 17.16-0.57MG-19.45MCG/ML* INJECTABLE, 5ml, Profe... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE 30-0.5 MG/ML INJECTABLE, 9ml, Professional Compoundin... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 30-2 MG-30 MCG/ML* INJECTABLE, 5ml, Profession... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 22-0.8 MG-8 MCG/ML* INJECTABLE, (a) 5ml (b) 10ml... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 HYDROXYPROGESTERONE CAPROATE 250 MG/ML OIL* INJECTABLE, (a) 10ml (b) 9ml inj... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE 30-1 MG/ML* INJECTABLE, (a)10ml (b) 9ml, penile inje... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.58MG-5.8MCG/ML* INJECTABLE, 5 ml, Profes... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 30-1 MG-10 MCG/ML* INJECTABLE, (a) 5ml, (b) 6m... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 30-1.6 MG-16 MCG/ML* INJECTABLE, (a) 5ml, (b) 10... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 9-1 MG-10 MCG/ML* INJECTABLE, 18 ml, Professiona... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops, Profess... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 15-0.5MG-10MCG/ML INJECTABLE, 9ml, Professional ... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 22.5-0.8MG-8.3MCG/ML INJECTABLE, 5 ml, Professio... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 DEXAMETHASONE (NAPO4) 0.1% OPHTH* PRES-FREE SOLUTION, 10ml, Eye Drops, Profes... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 ACETYL-L-CYSTEINE 10% P.F. OPHTH SOLUTION, 10ml, eye drops, Professional Comp... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 15-0.25MG-6MCG/ML INJECTABLE, 5 ml, Professional... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PGE1-LIDOCAINE 40 MCG-1% /ML* INJECTABLE, (a) 10 ml (b) 9ml, Professional Com... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 12-1MG-10MCG/ML INJECTABLE, (a) 10ml, (b) 9ml, P... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 17.64-0.58MG-5.88MCG/ML* INJECTABLE, 9 ml, Profe... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PGE1 40 MCG/ML* INJECTABLE, (2) 5ml (b) 10ml, (c) 6ml (d) 9ml, Professional C... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 23-0.96MG-19.2MCG/ML INJECTABLE, (a) 5ml, (b) 6.... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 16.6-0.55 MG-11.1 MCG/ML* INJECTABLE, 10 ml, Pro... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE 15-0.5MGMG/ML INJECTABLE, 9ml, Professional Compoundi... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...
Feb 21, 2019 PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Profes... Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs d... Class II Health Solutions Pharmacy Center Inc dba Profes...

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.