Browse Drug Recalls

2,157 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 2,157 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 2,157 FDA drug recalls.

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DateProductReasonClassFirm
Jan 7, 2020 Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET W... Microbial contamination of non-sterile product. Class III Sigan Industries Inc.
Dec 26, 2019 Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper ... Chemical contamination; out of specification results obtained for equipment cleaning residue rins... Class III Akorn, Inc.
Dec 20, 2019 Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro P... Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. Class I Taro Pharmaceuticals U.S.A., Inc.
Dec 6, 2019 Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, D... Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total ... Class I Lannett Company, Inc.
Nov 25, 2019 Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 11... Cross contamination with other products: undeclared contaminants of phenol and camphor in petrole... Class II OraLabs, Incorporated
Oct 31, 2019 LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Po... Microbial contamination of non-sterile product. Class II Fagron, Inc
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [ND... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets pe... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 t... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 23, 2019 Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per ... CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. Class II Perrigo Company PLC
Oct 9, 2019 PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride ... GMP Deviations: potential glass contamination Class II Nephron Pharmaceuticals Corporation dba Nephron...
Oct 9, 2019 PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chlo... GMP Deviations: potential glass contamination Class II Nephron Pharmaceuticals Corporation dba Nephron...
Oct 9, 2019 PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chlorid... GMP Deviations: potential glass contamination Class II Nephron Pharmaceuticals Corporation dba Nephron...
Sep 24, 2019 Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Re... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Redu... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reduce... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint A... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 24, 2019 Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Table... GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Class II Apotex Inc.
Sep 23, 2019 DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measu... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Sep 23, 2019 DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-... CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... Class II Unipharma, Llc.
Sep 18, 2019 Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30... Microbial Contamination of Non-Sterile Product. Class II GCP Laboratories Inc
Sep 12, 2019 Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG... CGMP Deviations: Received notice from supplier that there is potential glass contamination. Class II Spectrum Laboratory Products
Aug 30, 2019 Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit ... Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerob... Class I Plastikon Healthcare LLC
Aug 29, 2019 Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical ... cGMP Deviations: Potential glass contamination Class II Johnson Matthey Inc.
Aug 29, 2019 Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Ma... cGMP Deviations: Potential glass contamination Class II Johnson Matthey Inc.
Aug 29, 2019 Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceut... cGMP Deviations: Potential glass contamination Class II Johnson Matthey Inc.
Aug 14, 2019 RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 ta... Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas. Class II Pfizer Inc.
Aug 9, 2019 PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged... Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above... Class II Ridge Properties, LLC
Aug 9, 2019 PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, pac... Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above... Class II Ridge Properties, LLC
Jul 19, 2019 MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as o... Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed micro... Class II Dercher Enterprises, Inc., DBA Gordon Laboratories
Jul 16, 2019 Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 67877-537-07)... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 140 mg, packaged in a) 5-count bottle (NDC 67877-540-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 250 mg, 5-count bottle, Rx only, Manufactured by: Deva... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Clobazam Oral Suspension, 2.5 mg/mL, 120 mL bottle, Rx only, Distributed by: ... Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enume... Class II Bionpharma Inc.
Jul 16, 2019 Temozolomide Capsules, 20 mg, packaged in a) 5-count bottle (NDC 67877-538-07... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi
Jul 16, 2019 Temozolomide Capsules, 100 mg, packaged in a) 5-count bottle (NDC 67877-539-0... CGMP Deviations: product was manufactured that did not prevent possible cross contamination with ... Class II Deva Holding AS - Cerkezkoy Subesi

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.