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 20, 2018 | Gaia Kratom (mitragyna speciosa) powder, Green Horn, 1oz, 250g, 1kg packages,... | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Class I | Gaia Ethnobotanical LLC |
| Jun 20, 2018 | Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gai... | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Class I | Gaia Ethnobotanical LLC |
| Jun 20, 2018 | Gaia Kratom (mitragyna speciosa) powder, White Horn, 1oz, 250g, 1kg packages,... | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Class I | Gaia Ethnobotanical LLC |
| Jun 20, 2018 | Gaia Kratom (mitragyna speciosa) powder, Plantation White MD, 1oz, 250g, 1kg ... | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Class I | Gaia Ethnobotanical LLC |
| Jun 20, 2018 | Gaia Kratom (mitragyna speciosa) powder, Purple 8-1, 1oz, 250g, 1kg packages... | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Class I | Gaia Ethnobotanical LLC |
| Jun 20, 2018 | Gaia Kratom (mitragyna speciosa) powder, Red Bali, 1oz, 250g, 1kg packages, ... | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Class I | Gaia Ethnobotanical LLC |
| Jun 20, 2018 | Gaia Kratom (mitragyna speciosa) powder, Plantation Red MD, 1oz, 250g, 1kg pa... | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Class I | Gaia Ethnobotanical LLC |
| Jun 20, 2018 | Gaia Kratom (mitragyna speciosa) powder, Red Borneo, 1oz, 250g, 1kg packages... | Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination | Class I | Gaia Ethnobotanical LLC |
| May 22, 2018 | READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloth... | Microbial Contamination of a Non-Sterile Product. | Class II | Medline Industries Inc (Northpoint Services) |
| May 16, 2018 | Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches... | Microbial contamination of NonSterile Product; FDA analysis returned out of specification results... | Class II | Inopak Ltd |
| May 4, 2018 | B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatol... | Microbial Contamination of Non-sterile Product | Class II | Milbar Laboratories, Inc. |
| May 1, 2018 | Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Ma... | GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| May 1, 2018 | Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Ma... | GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... | Class II | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Apr 11, 2018 | NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Pre... | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... | Class II | Premier Pharmacy Labs Inc |
| Apr 11, 2018 | Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... | Class II | Premier Pharmacy Labs Inc |
| Apr 11, 2018 | Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... | Class II | Premier Pharmacy Labs Inc |
| Apr 11, 2018 | Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. ... | Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... | Class II | Premier Pharmacy Labs Inc |
| Apr 6, 2018 | Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bott... | Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisino... | Class III | Sandoz Incorporated |
| Mar 30, 2018 | PASTA DE LASSAR ANDROMACO Skin Protection, 25% zinc oxide Topical cream, 60 g... | Microbial Contamination of Non-Sterile Products | Class II | Marcas Usa Llc |
| Mar 5, 2018 | Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johns... | Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morph... | Class II | Johnson Matthey Inc. |
| Feb 14, 2018 | SyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 515... | Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paeci... | Class II | Fagron, Inc |
| Dec 28, 2017 | Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe a... | Microbial Contamination of Non-Sterile Products. | Class II | DLC Laboratories, Inc |
| Dec 19, 2017 | Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX O... | Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalpro... | Class II | Unichem Pharmaceuticals Usa Inc |
| Dec 12, 2017 | Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 ... | Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burk... | Class II | Woodfield Pharmaceutical, LLC |
| Nov 9, 2017 | GERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118... | Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans | Class I | Kareway Products Inc |
| Nov 8, 2017 | Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. ... | Microbial Contamination of Non-Sterile Products | Class II | L. Perrigo Company |
| Sep 27, 2017 | FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bu... | Microbial Contamination of Non-Sterile Products | Class II | Pfizer Manufacturing Deutschland GmbH |
| Sep 20, 2017 | Fluocinonide Gel USP, 0.05%, 15 g tube, Rx Only, Mfd. by: Taro Pharmaceutical... | Cross contamination with other products: traces of Dapsone were found in the finished product. | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Aug 30, 2017 | Doctor Manzanilla Allergy & Decongestant Relief (diphenhydramine hydrochlori... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Mid Valley Pharmaceutical |
| Aug 30, 2017 | Doctor Manzanilla Cough & Cold (diphenhydramine hydrochloride and phenylephri... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Mid Valley Pharmaceutical |
| Aug 23, 2017 | Option Systems Antibacterial Foaming Hand Wash, 0.3% P.C.M.X., 8 fl oz and 18... | GMP Deviations; potential bacterial contamination may have been introduced to products through a ... | Class II | Inopak Ltd |
| Aug 23, 2017 | Mild Healthcare Antibacterial Hand Soap, 6% P.C.M.X., 1000 mL and 2000 mL Dis... | GMP Deviations; potential bacterial contamination may have been introduced to products through a ... | Class II | Inopak Ltd |
| Aug 23, 2017 | Choice Antibacterial Hand Soap, (ethyl alcohol 61%) 800 ml/ 27 fl oz, Univer... | GMP Deviations; potential bacterial contamination may have been introduced to products through a ... | Class II | Inopak Ltd |
| Aug 22, 2017 | Toothette Oral Care Suction Toothbrushes with Perox-A-Mint solution. Contains... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Q Care RX Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Glucona... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Toothette Suction Toothbrush with Perox-A-Mint solution and Mouth Moisturizer... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Toothette Oral Care Short-Term Oral Swab System with Perox-A-Mint solution, C... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Toothette Oral Care Suction Toothbrushes with Antiseptic Oral Rinse and Mouth... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yank... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Oral Cleansing & Suctioning System q2 with 0.12% Chlorexidine Gluconate (CHG)... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Q Care Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Q.Care, Oral Cleansing & Suctioning System q4. Contains: 1 Covered Yankauer a... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Q.Care Oral Cleansing & Suctioning System with 0.12% Chlorhexidine Gluconate ... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Q Care Continue Care for the non-ventilated patient. Contains, 1 Covered Yank... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Oral Cleaning and Suctioning System q2. Contains 1 Covered Yankauer, 2 Untrea... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Q.CareOral Cleansing & Suctioning System q2. Contains 1 Covered Yankauer Suct... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Toothette Oral Care Perox-A- Mint solution, Oral Debriding Agent 8 fl oz/237 ... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Toothette Oral Care Q Care & Suctioning System. Contains 1 Covered Yankauer,... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Nose to Toes Skin Antisepsis, Oral Cleansing and Nasal Antisepsis System. Con... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products Inc |
| Aug 22, 2017 | Independent Care System Corinz, Contains: 1.5 fl oz bottle Corinz Mouthwash, ... | Cross Contamination With Other Products: Oral care solutions were manufactured by a third party s... | Class II | Sage Products 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.