Browse Drug Recalls
3,430 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,430 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 3,430 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 7, 2022 | Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg p... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg M... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dext... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per ... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 ... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cu... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 c... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 ... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cup... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 1... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 c... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cup... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 6, 2022 | Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed a... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jun 6, 2022 | Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed a... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jun 6, 2022 | Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jun 3, 2022 | Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose via... | CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 3, 2022 | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... | CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rej... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 18, 2022 | Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Lif... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Li... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Lif... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 17, 2022 | AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | AMBI Skincare Fade Cream Oily Skin New & Improved, Net Wt. 2 OZ (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily Facial Mois... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne Treatment Wit... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E Advanced Al... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E, 8 FL. OZ. ... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 17, 2022 | Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat & Rich Emol... | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| May 13, 2022 | Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Zonisamide Capsules USP, 100 mg, 90-count bottle, Rx Only, Packaged and Dist... | CGMP Deviations: Gaps in the quality system in the Quality Control microbiology laboratory. | Class II | Direct Rx |
| May 13, 2022 | Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Wash... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Morbillinum, Potency:7C, 8C, 9C, 10C 12C, 13C, 15C, 20C, 21C, 30C, 200 C,Liqu... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Streptococcinum, Potency: 8C, 9C, 30C, 200C, Liquid Pellets, Rx only, Washin... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washi... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington ... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets, OTC, Washington Hom... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Pyrogenium, Potency: 15X, 16X, 17X, 19X, 21X, 22X, 25X, 30X, 1M, 200C, 30C, O... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Colibacillinum, Potency: 12C, 14C, 15C, 18C, 20C, 30C, Liquid Pellets, OTC, W... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Diphtherinum, Potency: 14C, 30C, 200C, Liquid Pellets, Rx only, Washington Ho... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Syphilinum, Potency: 9C, 30C, 200C, 10X, 12X, Liquid Pellets, Rx only, Washi... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C, 19C, 24C, 25C, 26C... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington ... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Anthracinum, Potency: 6C, 7C, 8C, 9C, 12C, 14C, 30C, 200C, 11X, 14X, 30X Liqu... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Proteus, Potency: 7C, 8C, 9C, 12C, 15C, 16C, 20C, 30C, 200C, OTC, Liquid Pell... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 13, 2022 | Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Hom... | cGMP deviations | Class II | Washington Homeopathic Products, Inc. |
| May 11, 2022 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distribute... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Class II | Direct Rx |
| May 11, 2022 | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-Sterile Solutio... | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specificatio... | Class II | A.P. Nonweiler |
| May 11, 2022 | Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Class II | Direct Rx |
| May 11, 2022 | Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distribut... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits . | Class II | Direct Rx |
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.