Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 7, 2024 | Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-83... | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Aurobindo Pharma USA Inc |
| Nov 7, 2024 | Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-83... | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Aurobindo Pharma USA Inc |
| Nov 7, 2024 | Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832... | cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Aurobindo Pharma USA Inc |
| Nov 6, 2024 | MAXIM Assure Antibacterial, Chloroxylenol 0.1%, Net Contents: One U.S. Gallo... | cGMP Deviations: Out of specification results for micro in hand soap products. | Class II | Midlab Incorporated |
| Nov 6, 2024 | Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L),... | cGMP Deviations: Out of specification results for micro in hand soap products. | Class II | Midlab Incorporated |
| Nov 6, 2024 | Compliance Dishwashing Liquid & Antibacterial Soap, PCMX 0.1%, Net Contents: ... | cGMP Deviations: Out of specification results for micro in hand soap products. | Class II | Midlab Incorporated |
| Nov 6, 2024 | boardwalk ANTIBACTERIAL HANDSOAP REFILL, Chloroxylenol 0.1%, 1 gal. (3.78 L),... | cGMP Deviations: Out of specification results for micro in hand soap products. | Class II | Midlab Incorporated |
| Nov 6, 2024 | Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ... | cGMP Deviations: Out of specification results for micro in hand soap products. | Class II | Midlab Incorporated |
| Nov 6, 2024 | ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ... | cGMP Deviations: Out of specification results for micro in hand soap products. | Class II | Midlab Incorporated |
| Nov 1, 2024 | Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in b... | cGMP Deviations | Class II | JR Watkins |
| Nov 1, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Ca... | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 1, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dos... | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 1, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dos... | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 1, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dos... | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 1, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 C... | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Nov 1, 2024 | Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosa... | cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Oct 24, 2024 | HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per bo... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distribute... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distri... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Dist... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical A... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 24, 2024 | THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactur... | cGMP Deviations | Class II | Unexo Life Sciences Private Limited |
| Oct 23, 2024 | Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC ... | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Class II | Lupin Pharmaceuticals Inc. |
| Oct 23, 2024 | Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count ND... | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Class II | Lupin Pharmaceuticals Inc. |
| Oct 23, 2024 | Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC... | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor | Class II | Lupin Pharmaceuticals Inc. |
| Oct 15, 2024 | OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Lax... | CGMP Deviations | Class II | Akron Pharma, Inc. |
| Oct 10, 2024 | Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-1... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | ACCORD HEALTHCARE, INC. |
| Oct 10, 2024 | Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | ACCORD HEALTHCARE, INC. |
| Oct 10, 2024 | Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, M... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc |
| Oct 10, 2024 | Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-... | CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab... | Class II | ACCORD HEALTHCARE, INC. |
| Oct 9, 2024 | Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 9, 2024 | Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratorie... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 9, 2024 | Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories... | CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 8, 2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 128 FL OZ. (3785.4 mL... | CGMP violations. | Class II | Neogen Corporation |
| Oct 8, 2024 | LICEOUT, Liquid Lice Treatment for Human Use, Contents: 1 FL. OZ. (29.6 mL) p... | CGMP violations. | Class II | Neogen Corporation |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... | CGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single D... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Do... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose ... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose B... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... | cGMP violations | Class II | Fresenius Kabi Compounding, LLC |
| Sep 25, 2024 | NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL... | cGMP violations | Class II | Fresenius Kabi Compounding, 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.