Browse Drug Recalls
2,021 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,021 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 2,021 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 4, 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufact... | Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... | Class III | SOMERSET THERAPEUTICS LLC |
| Jun 4, 2020 | Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufact... | Failed Impurities/Degradation Specification: There is a slow leaching process from the product l... | Class III | SOMERSET THERAPEUTICS LLC |
| Jun 3, 2020 | Rocky Mountain Sunscreen SPF30 Kiwi Flavored Lip Balm (Oxybenzone 5%, Meradim... | Superpotent Drug: Active Ingredient Octisalate found at 15% above label claim. | Class II | Yusef Manufacturing Laboratories, LLC |
| May 28, 2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ (177 mL), Distrib... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ (355 mL) single p... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. (355 ... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 28, 2020 | Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distri... | Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle la... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| May 19, 2020 | LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in ... | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... | Class II | Wuhan Bingbing Pharmaceutical Co., Ltd. |
| May 19, 2020 | Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 pat... | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... | Class II | Wuhan Bingbing Pharmaceutical Co., Ltd. |
| May 19, 2020 | Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured ... | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... | Class II | Wuhan Bingbing Pharmaceutical Co., Ltd. |
| May 19, 2020 | LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches pe... | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... | Class II | Wuhan Bingbing Pharmaceutical Co., Ltd. |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Apr 20, 2020 | ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ... | Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... | Class III | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops ... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Advil Liqui-Gel Mini 160+20+20 CT (e-commerce) NDC # 0573-1715-59 SKU# F005... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Advil Sinus Congestion and Pain/Advil Allergy and Congestion Relief 8 pc with... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. A... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| Mar 16, 2020 | Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bot... | Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning infor... | Class II | Glaxosmithkline Consumer Healthcare Holdings |
| 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 4, 2020 | PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par... | Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Pre... | Class III | Par Pharmaceutical Inc. |
| Mar 3, 2020 | PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g... | Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for ... | Class II | Yusef Manufacturing Laboratories, LLC |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 14, 2020 | Discount Drug Mart, Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 m... | Labeling: Incorrect or Missing Lot and/or Expiration date. | Class III | AAA Pharmaceutical, Inc. |
| Feb 12, 2020 | TRAMADOL HYDROCHLORIDE Tablets, USP, 50 mg, Rx Only a)100-count bottles (NDC ... | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ... | Class III | Golden State Medical Supply Inc. |
| Feb 10, 2020 | Frovatriptan Succinate Tablets, 2.5mg, packaged in 1 blister card of 9 tablet... | Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiratio... | Class III | Par Pharmaceutical Inc. |
| Feb 7, 2020 | Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only... | Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may ... | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Jan 29, 2020 | Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufa... | Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure... | Class III | UNICHEM PHARMACEUTICALS USA INC |
| Jan 28, 2020 | Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufact... | Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tabl... | Class II | Graviti Pharmaceuticals Private Limited |
| Jan 28, 2020 | Kushim Tablets (Gushim) 45-count packages, Label in foreign language | Marketed Without an Approved NDA/ANDA. FDA analysis found product to contain cinobufagin, bufalin... | Class II | B AND A TRADING CORPORATION |
| Jan 28, 2020 | Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottl... | Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets ... | Class III | Teva Pharmaceuticals USA |
| Jan 14, 2020 | methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only... | Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to rec... | Class III | Hikma Pharmaceuticals USA Inc. |
| Dec 27, 2019 | Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repacka... | Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer... | Class I | RemedyRepack Inc. |
| Dec 23, 2019 | Theraflu Cough Relief, Dextromethorphan HBr and Guaifensin, 6 packets per car... | Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the prod... | Class II | GSK Consumer Health, Inc |
| Dec 18, 2019 | Liothyronine (T3) 80 mcg SR cap | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | T3/T4 SR 9 mcg/38 mcg capsule | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Tadalafil 20 mg Troche | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | DHEA/Pregnenol One 10.25 MG Cap | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Liothyronine (T3) 92.5 MCG | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Progesterone 50 mg capsules | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Sildenafil 200 mg Troche (Clinic) | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Magic Bullet Supplement | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Finasteride/Biotin 1 mg/50 mcg | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Testosterone Topical Cream 4% | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Progesterone E4M SR 100 mg capsules | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Sildenafil 80 mg capsules | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
| Dec 18, 2019 | Lidocaine/Priloc/PE 30/5/0.25% 30 GM jars | Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired... | Class II | MPRX, Inc. dba Medical Park Pharmacy |
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.