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Browse Drug Recalls

3,374 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,374 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 3,374 FDA drug recalls.

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DateProductReasonClassFirm
Mar 24, 2020 Acne Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA,... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 24, 2020 Bleeding Stop, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 ... CGMP Deviations: These products have been found to be misbranded as unapproved new drugs Class II Herbal Doctor Remedies
Mar 18, 2020 Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx ... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aur... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Auro... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 18, 2020 Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bot... CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed Class II Aurobindo Pharma USA Inc.
Mar 13, 2020 Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... Class II Sun Pharmaceutical Industries, Inc.
Mar 13, 2020 Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... Class II Sun Pharmaceutical Industries, Inc.
Mar 11, 2020 Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg, 90 count bottle, Rx ... CGMP Deviations: Presence of dark brown discoloration on edges of tablets Class II Jubilant Cadista Pharmaceuticals, Inc.
Mar 6, 2020 Theophylline (Anhydrous) Extended-Release Tablets, 400 mg, 100-count bottle, ... CGMP Deviations: poor manufacturing practices resulted in Labeling: Incorrect or Missing Lot and/... Class II Nostrum Laboratories Inc
Mar 5, 2020 Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: ... CGMP Deviation: Chemical indicators were not positioned properly during sterilization process. Class II Fresenius Medical Care Holdings, Inc.
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.

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.