Browse Drug Recalls
1,528 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,528 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 1,528 FDA drug recalls in FL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 3, 2019 | Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses a... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth ... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL P... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packa... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Clonidine HCL and Baclofen in all strengths, all doses and all packaging, Ana... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all s... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all dose... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth ... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all pac... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all pac... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all ... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all s... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, a... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoo... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 ... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses a... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, A... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 571... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, ... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all ... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all st... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all st... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packag... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all pack... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, al... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fent... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate ... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Sep 3, 2019 | Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses ... | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... | Class II | Coast Quality Pharmacy, LLC dba Anazao Health |
| Aug 30, 2019 | Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single u... | Lack of assurance of sterility. | Class II | Pacifico National, Inc. dba AmEx Pharmacy |
| Aug 30, 2019 | Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single ... | Lack of assurance of sterility. | Class II | Pacifico National, Inc. dba AmEx Pharmacy |
| Jul 15, 2019 | CVS Health Children's Nasal Saline Drops with Himalayan Salt Saline Nasal Moi... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Jul 15, 2019 | CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Jul 15, 2019 | DrKids Children's Allergy Relief Diphenhydramine HCl 12.5 mg/5 mL Antihistami... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Jun 21, 2019 | ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (7... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Anal... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (11... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl,... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical ... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.1... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin),... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnic... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufacture... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manu... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural Inc. |
| Jun 21, 2019 | DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml... | CGMP Deviations: products were manufactured with lack of process validation, cleaning validation,... | Class II | Pharma-Natural 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.