Browse Drug Recalls
3,394 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,394 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 3,394 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 13, 2023 | Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... | cGMP deviations | Class II | Direct Rx |
| Mar 13, 2023 | Glimepiride, USP, 4 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... | cGMP deviations | Class II | Direct Rx |
| Mar 13, 2023 | Ropinirole, USP, 0.25 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC... | cGMP deviations | Class II | Direct Rx |
| Mar 13, 2023 | Simvastatin, USP, 40 mg, Rx Only, Packaged as a 90-count bottle, NDC 61919-04... | cGMP deviations | Class II | Direct Rx |
| Mar 13, 2023 | Simvastatin, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 6... | cGMP deviations | Class II | Direct Rx |
| Mar 13, 2023 | Glimepiride, USP, 1 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, ND... | cGMP deviations | Class II | Direct Rx |
| Mar 2, 2023 | Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 5199... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 5... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 519... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Feb 24, 2023 | Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in ... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) p... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Aci... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed b... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid o... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (20... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camp... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 23, 2023 | NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid D... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Nutraceutical Corporation |
| Feb 23, 2023 | NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), ... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Nutraceutical Corporation |
| Feb 23, 2023 | NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, ... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Nutraceutical Corporation |
| Feb 23, 2023 | NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% A... | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Class II | Nutraceutical Corporation |
| Feb 23, 2023 | Sterile Water for Injection, USP, 30x5 mL Single-Dose Vials, Rx Only, Nephron... | CGMP Deviations: Potential product carryover. | Class II | Nephron Sc Inc |
| Feb 22, 2023 | Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, R... | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | Teva Pharmaceuticals USA Inc |
| Feb 21, 2023 | Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV B... | CGMP DEVIATIONS | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 21, 2023 | Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters... | CGMP DEVIATIONS | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 21, 2023 | Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiter... | CGMP DEVIATIONS | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 21, 2023 | Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV ... | CGMP DEVIATIONS | Class II | Denver Solutions, LLC DBA Leiters Health |
| Feb 15, 2023 | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL, packaged in: a) 10 mL... | cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials. | Class II | Azurity Pharmaceuticals, Inc. |
| Feb 14, 2023 | Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles,... | CGMP Deviations | Class II | Pharmedica USA, LLC |
| Feb 9, 2023 | New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain s... | cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. | Class II | HTO Nevada, Inc. |
| Feb 9, 2023 | Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive ... | cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API. | Class II | HTO Nevada, Inc. |
| Feb 7, 2023 | Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bott... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 1... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Acc... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-1... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, R... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 167... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufa... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactur... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, 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.