Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 5, 2020 | Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled ... | CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-market... | Class II | Teva Pharmaceuticals USA |
| Feb 28, 2020 | Sunstar GUM Toothpaste 3 g tubes, Toothpaste made in Japan, packed in China, ... | cGMP Deviation | Class II | Sunstar Guangzhou Ltd. |
| Jan 31, 2020 | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial, Rx Only, ... | cGMP Deviations | Class II | Zydus Pharmaceuticals USA Inc |
| Jan 27, 2020 | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-c... | CGMP deviations: Product bottle may be absent of desiccant. | Class II | Teva Pharmaceuticals USA |
| Jan 27, 2020 | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-c... | CGMP deviations: Product bottle may be absent of desiccant. | Class II | Teva Pharmaceuticals USA |
| Jan 24, 2020 | Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactu... | cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API sour... | Class II | Ascend Laboratories LLC |
| Jan 24, 2020 | Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51... | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... | Class II | Breckenridge Pharmaceutical, Inc |
| Jan 24, 2020 | Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 5199... | CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin ... | Class II | Breckenridge Pharmaceutical, Inc |
| Jan 15, 2020 | Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Dir... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Direct Rx |
| Jan 15, 2020 | Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-3... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Direct Rx |
| Jan 14, 2020 | Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL ... | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... | Class II | Sun Pharmaceutical Industries, Inc. |
| Jan 14, 2020 | Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp.,... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Spectrum Laboratory Products |
| Jan 14, 2020 | Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Sin... | cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... | Class II | Sun Pharmaceutical Industries, Inc. |
| Jan 10, 2020 | Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.0... | CGMP Deviations: Out of specification test result observed during retrospective review of blend u... | Class III | Lupin Pharmaceuticals Inc. |
| Jan 10, 2020 | ranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 430... | CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts ... | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jan 7, 2020 | Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the ... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 7, 2020 | Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Appco Pharma LLC |
| Jan 7, 2020 | Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 037... | CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the ... | Class II | Mylan Pharmaceuticals Inc. |
| Jan 7, 2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 co... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Preferred Pharmaceuticals, Inc |
| Jan 7, 2020 | Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottl... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Preferred Pharmaceuticals, Inc |
| Jan 7, 2020 | Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Appco Pharma LLC |
| Jan 6, 2020 | Ranitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | H J Harkins Company Inc dba Pharma Pac |
| Dec 26, 2019 | Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | AAA Pharmaceutical, Inc. |
| Dec 26, 2019 | Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | AAA Pharmaceutical, Inc. |
| Dec 20, 2019 | Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 2... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Denton Pharma, Inc. |
| Dec 20, 2019 | Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 9... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Denton Pharma, Inc. |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Gl... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: G... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 17, 2019 | Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Gl... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Glenmark Pharmaceuticals Inc., USA |
| Dec 13, 2019 | RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA ND... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Granules India Limited |
| Dec 11, 2019 | Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repac... | CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts a... | Class II | RemedyRepack Inc. |
| Dec 2, 2019 | Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03),... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Preferred Pharmaceuticals, Inc |
| Nov 22, 2019 | Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).1... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Amneal Pharmaceuticals, Inc. |
| Nov 22, 2019 | Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Amneal Pharmaceuticals, Inc. |
| Nov 22, 2019 | Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).1... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Amneal Pharmaceuticals, Inc. |
| Nov 22, 2019 | Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Amneal Pharmaceuticals, Inc. |
| Nov 22, 2019 | Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | Amneal Pharmaceuticals, Inc. |
| Nov 20, 2019 | Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), ... | CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... | Class II | American Health Packaging |
| Nov 14, 2019 | AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. ... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | AVKARE Inc. |
| Nov 14, 2019 | AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, I... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | Class II | AVKARE Inc. |
| Nov 14, 2019 | Yeast Arrest, Homeopathic Formula, Vaginal Support suppositories, packaged in... | cGMP violations | Class II | Wisconsin Pharmacal Company, LLC |
| Nov 13, 2019 | Ranitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per c... | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API. | Class II | Precision Dose Inc. |
| Nov 8, 2019 | Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively ... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Natrum Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India ex... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic Products, Inc. |
| Nov 8, 2019 | Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India ex... | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Class II | Washington Homeopathic 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.