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Browse Drug Recalls

6 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6 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 6 FDA drug recalls.

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DateProductReasonClassFirm
Oct 21, 2019 PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, ... Incorrect labeling: Incorrect or missing lot and/or exp date Class III Nephron Pharmaceuticals Corporation dba Nephron...
Oct 9, 2019 PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride ... GMP Deviations: potential glass contamination Class II Nephron Pharmaceuticals Corporation dba Nephron...
Oct 9, 2019 del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephr... Lack of Assurance of Sterility; bags have potential to leak Class II Nephron Pharmaceuticals Corporation dba Nephron...
Oct 9, 2019 PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chlo... GMP Deviations: potential glass contamination Class II Nephron Pharmaceuticals Corporation dba Nephron...
Oct 9, 2019 PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chlorid... GMP Deviations: potential glass contamination Class II Nephron Pharmaceuticals Corporation dba Nephron...
Oct 9, 2019 Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysi... Lack of Assurance of Sterility; bags have potential to leak Class II Nephron Pharmaceuticals Corporation dba Nephron...

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.