Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 31, 2018 | Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glas... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 31, 2018 | Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) pe... | CGMP Deviations: products manufactured by contract manufacturer under conditions that could resul... | Class II | Beaumont Bio-med, Inc. |
| Aug 30, 2018 | Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum,... | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... | Class II | Alkano Chemicals, Inc |
| Aug 28, 2018 | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... | Class II | Humco Holding Group, Inc |
| Aug 28, 2018 | Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 ... | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... | Class II | Humco Holding Group, Inc |
| Aug 28, 2018 | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grai... | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... | Class II | Humco Holding Group, Inc |
| Aug 24, 2018 | Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co.,... | CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine a... | Class II | LGM Pharma LLC |
| Aug 24, 2018 | Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) ... | CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... | Class II | Valeant Pharmaceuticals North America LLC |
| Aug 24, 2018 | Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Di... | CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... | Class II | Valeant Pharmaceuticals North America LLC |
| Aug 24, 2018 | Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in c... | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... | Class II | RemedyRepack Inc. |
| Aug 24, 2018 | Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. ... | CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products ... | Class II | Valeant Pharmaceuticals North America LLC |
| Aug 22, 2018 | THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothy... | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... | Class II | Syntec Pharma Corp |
| Aug 22, 2018 | THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/... | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels... | Class II | Syntec Pharma Corp |
| Aug 21, 2018 | 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Co... | CGMP Deviations | Class II | Baxter Healthcare Corporation |
| Aug 21, 2018 | Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical C... | CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine... | Class II | Sichuan Friendly Pharmaceutical Co.,Ltd. |
| Aug 20, 2018 | Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles ... | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an act... | Class II | RemedyRepack Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/320 mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, R... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 5 mg/160 mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Valsartan Tablets USP, 80mg, 90 tablets per bottle, Rx Only, Manufactured by:... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/320 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine and Valsartan Tablets, USP, 10 mg/160mg, 30 tablets per bottle, Rx... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/25 m... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 17, 2018 | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 10 mg/160 mg/12.5... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Torrent Pharma Inc. |
| Aug 15, 2018 | Valsartan Tablets USP 320 mg, 90-count, plastic child resistant bottle, Rx On... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Preferred Pharmaceuticals, Inc |
| Aug 14, 2018 | Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit ... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-7... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-78... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 14, 2018 | Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-78... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | AVKARE Inc. |
| Aug 10, 2018 | Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, Rem... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 10, 2018 | Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, Reme... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | RemedyRepack Inc. |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx O... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Onl... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx On... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 8, 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles,... | CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. | Class II | Hetero Labs Limited Unit V |
| Aug 3, 2018 | Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slipper... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube,... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochlo... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distribu... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | TopCare, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14 g) tube, Distributed... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturi... | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing LLC |
| Aug 3, 2018 | Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562. | CGMP Deviations: products manufactured under conditions that could impact its product quality. | Class II | Product Quest Manufacturing 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.