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Browse Drug Recalls

3,368 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 3,368 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 3,368 FDA drug recalls.

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DateProductReasonClassFirm
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 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, 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
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
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, 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, 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 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 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 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 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 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 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 Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X, 9C, 10C, 13C, 15... 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 Medorrhinum, Potency:12C, 30C, 200C, 1M, Liquid Pellets, Rx only, Washington ... 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 Tuberculinum Bovinum, Potency: 12C, 30C, 200C, Liquid Pellets, Rx only, Wash... 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 Tuberculinum, Potency: 1X, 12X, 24X, 30X, 1M, 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 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 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 Vaccinotoxinum, Potency: 32X, 11C, 30C, Liquid Pellets, Rx only, Washington ... 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 Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C, 12C, 30C 1M, Liquid... 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 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
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 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 5, 2022 Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonv... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Direct Rx
May 4, 2022 Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repac... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II RemedyRepack Inc.
May 3, 2022 Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5 ... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Preferred Pharmaceuticals, Inc.
May 3, 2022 Losartan Potassium & HCTZ Tablets 50mg/12.5 mg, hydrochlorothiazide USP 12.5,... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Preferred Pharmaceuticals, Inc.
May 2, 2022 Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged ND... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Class II RemedyRepack Inc.
May 2, 2022 Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC ... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. Class II RemedyRepack Inc.
Apr 25, 2022 Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manu... cGMP deviations Class II Glenmark Pharmaceuticals Inc., USA
Apr 25, 2022 Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharm... CGMP Deviations Class II SCA Pharmaceuticals
Apr 25, 2022 Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manuf... cGMP deviations Class II Glenmark Pharmaceuticals Inc., USA
Apr 25, 2022 Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462... cGMP deviations Class II Glenmark Pharmaceuticals Inc., USA
Apr 25, 2022 Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, ... CGMP Deviations Class II SCA Pharmaceuticals
Apr 25, 2022 Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceu... CGMP Deviations Class II SCA Pharmaceuticals

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.