Browse Drug Recalls
1,732 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,732 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 1,732 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 3, 2021 | Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx O... | Superpotent Drug | Class I | Teligent Pharma, Inc. |
| Aug 2, 2021 | 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE IN... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Je Dois Lavoir LLC |
| Jul 16, 2021 | ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distrib... | Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil | Class I | Alpha-Tek LLC |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | Chemical Contamination: presence of benzene | Class I | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4... | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. | Class I | Qikmoov LLC |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | Chemical Contamination: presence of benzene | Class I | Johnson & Johnson Consumer, Inc. |
| Jul 2, 2021 | Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By... | Temperature abuse: the firm received customer complaints of unusual grittiness in the product. | Class I | KVK-Tech, Inc. |
| Jun 22, 2021 | Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured... | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... | Class I | Ardil Comercial S.R.L. |
| Jun 21, 2021 | Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitiz... | Hand sanitizer packaged in bottles that resemble beverage containers. | Class I | Prairie Wolf Spirits |
| Jun 18, 2021 | Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceutical... | Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. ... | Class I | Teva Pharmaceuticals USA |
| May 18, 2021 | PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6),... | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Class I | Miracle 8989 |
| May 18, 2021 | maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), D... | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Class I | Miracle 8989 |
| May 18, 2021 | PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per ... | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Class I | Miracle 8989 |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... | Class I | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... | Class I | Global Sanitizers LLC |
| May 11, 2021 | Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Pos... | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalaf... | Class I | Yamtun7 |
| May 11, 2021 | C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Comp... | Non-Sterility | Class I | People's Custom Rx and Clinical Care, LLC |
| May 11, 2021 | DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distribut... | Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label c... | Class I | DIBAR NUTRICIONAL S DE RL DE CV |
| May 3, 2021 | 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose v... | Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U... | Class I | PFIZER, INC |
| May 3, 2021 | 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL ... | Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U... | Class I | PFIZER, INC |
| Apr 29, 2021 | NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-coun... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 29, 2021 | NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-coun... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 29, 2021 | NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-coun... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 29, 2021 | NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 29, 2021 | NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx ... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topi... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net W... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile T... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.3... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Top... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile To... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 20, 2021 | BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate... | Defective Delivery System: An increase in complaints identified endcap being loose or falling off... | Class I | CareFusion 213, LLC |
| Apr 8, 2021 | Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Ang... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or ta... | Class I | NSNY Distributor Inc |
| Apr 8, 2021 | Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra... | Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or ta... | Class I | NSNY Distributor Inc |
| Mar 30, 2021 | Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count ... | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... | Class I | Ummzy, LLC |
| Mar 30, 2021 | Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, M... | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... | Class I | Ummzy, LLC |
| Mar 30, 2021 | Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in ... | Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... | Class I | Ummzy, LLC |
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.