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.

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DateProductReasonClassFirm
Jun 23, 2022 AMBI NRSHNG DAILY FACIAL MSTURZER 1.7 OZ distributed to specific Family Dolla... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 FW ASPIRIN CHEWABLE TABLET 36CT SKU 913990 GS ENTERIC ASPIRIN TABLET 120 CT ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL O... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 QP MOTION SICKNESS TABLET 8 CT distributed to specific Family Dollar Stores 0... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GC MILK OF MAGNESIA CHERRY 12 FL OZ SKU 915000 GC MILK OF MAGNESIA MINT 12 ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 VICKS VAPOCOOL DROPS SEVERE 18 CT SKU 999488 BEST HEALTH HONEY LEMON COUGH ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 SUAVE INV SLD PWDR 1.2 OZ SKU2004504 SUAVE AP INV SOLID SWEET PEA 1.2 OZ SK... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GOOD SENSE LICE SHAMPOO 6FL OZ distributed to specific Family Dollar Stores 0... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 21, 2022 Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-d... cGMP - Water leakage Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 10, 2022 Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 ... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Jun 7, 2022 CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL),... 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 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 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 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 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 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 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 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 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 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 MILK OF MAGNESIA USP, 2400 mg/10 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 13, 2022 Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington ... 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 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 Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, Liquid Pellets, Rx only, Washi... 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 Bacillinum Pulmo, Potency: 30C, 200C, Liquid Pellets, Rx only, Washington Hom... 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.

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.