Browse Drug Recalls
1,723 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,723 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 1,723 FDA drug recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 19, 2024 | Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 19, 2024 | Weiner Boner Honey, 12g packet, 100% Organic Formula. | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... | Class I | Pyramids Wholesale Inc. |
| Mar 4, 2024 | Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenou... | Presence of Particulate Matter. | Class I | Par Sterile Products LLC |
| Feb 15, 2024 | Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial ... | Presence of Particulate Matter | Class I | Eugia US LLC |
| Feb 12, 2024 | ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-c... | Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... | Class I | FA Online Inc |
| Feb 6, 2024 | Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distribut... | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undecla... | Class I | Today The World |
| Feb 6, 2024 | SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distrib... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Today The World |
| Feb 6, 2024 | Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Today The World |
| Feb 5, 2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, D... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Super Chill Products |
| Feb 1, 2024 | To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing ... | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. | Class I | Integrity Products |
| Feb 1, 2024 | RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a ... | Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. | Class I | Integrity Products |
| Feb 1, 2024 | TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 o... | Chemical Contamination; presence of benzene. | Class I | Insight Pharmaceuticals LLC, a Prestige Consume... |
| Jan 12, 2024 | Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Di... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Neptune Resources, LLC |
| Jan 12, 2024 | Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, ... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Neptune Resources, LLC |
| Jan 12, 2024 | Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wi... | Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... | Class I | Neptune Resources, LLC |
| Jan 4, 2024 | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,... | Labeling: Label Mix-up | Class I | Azurity Pharmaceuticals, Inc. |
| Dec 28, 2023 | PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Ite... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL)... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F320... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL)... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 28, 2023 | VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F32... | Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... | Class I | Denver Solutions, LLC DBA Leiters Health |
| Dec 26, 2023 | Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorph... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| Dec 26, 2023 | Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramin... | Microbial Contamination of Non-Sterile Products | Class I | Haleon US Holdings LLC |
| Dec 21, 2023 | Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABB... | Presence of Particulate Matter; identified as glass | Class I | Pfizer Inc. |
| Dec 21, 2023 | Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can... | Chemical Contamination: presence of benzene | Class I | Insight Pharmaceuticals LLC, a Prestige Consume... |
| Dec 21, 2023 | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL), Lifeshield, ... | Presence of Particulate Matter; identified as glass | Class I | Pfizer Inc. |
| Dec 21, 2023 | Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop ... | Presence of particulate matter: glass | Class I | PFIZER |
| Dec 21, 2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJE... | Presence of Particulate Matter; identified as glass | Class I | Pfizer Inc. |
| Nov 29, 2023 | Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed... | Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutic... | Class I | Meta Herbal |
| Nov 22, 2023 | SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL b... | Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals | Class I | Novartis Pharmaceuticals Corporation |
| Nov 22, 2023 | TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET... | Chemical Contamination; presence of benzene. | Class I | Insight Pharmaceuticals Corporation |
| Nov 17, 2023 | Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx O... | Defective Container: powder may leak out of the pouch | Class I | InvaGen Pharmaceuticals, Inc. |
| Nov 13, 2023 | Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) e... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glyco... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), pa... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packag... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) pack... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% a... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged ... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Prop... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, T... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
| Nov 13, 2023 | Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydro... | Non-Sterility | Class I | Kilitch Healthcare India Limited |
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.