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Browse Drug Recalls

13 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 13 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 13 FDA drug recalls.

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DateProductReasonClassFirm
May 10, 2024 Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Rel... Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on ... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), ... Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed),... Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixe... Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
May 10, 2024 Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixe... Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP... Class III Bryant Ranch Prepack, Inc.
Apr 20, 2023 Lidocaine Patch 5%, 1 patch (63629-8755-20) packaged in 30-count patches per ... Labeling: Typographical error on the upper left-hand side of the box and individual patch label t... Class III Bryant Ranch Prepack, Inc.
Jun 17, 2022 Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx ... Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta... Class I Bryant Ranch Prepack, Inc.
Jun 17, 2022 Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx ... Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta... Class I Bryant Ranch Prepack, Inc.
Oct 12, 2021 Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60... Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actua... Class I Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 28, 2021 Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC... Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... Class III Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 28, 2021 Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:... Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... Class III Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 27, 2021 Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 636... Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 25 mg may contain spironolact... Class I Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 27, 2021 Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Ma... Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolact... Class II Bryant Ranch Prepack, Inc. dba BRP 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.