Browse Drug Recalls

15 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 15 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 15 FDA drug recalls.

Clear
DateProductReasonClassFirm
Sep 29, 2025 Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distribu... Failed dissolution specifications: Stability testing found that the lot did not meet dissolution ... Class II Acella Pharmaceuticals, LLC
Apr 24, 2024 Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle... Subpotent drug Class III Acella Pharmaceuticals, LLC
Nov 14, 2022 Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10... Labeling: Not elsewhere classified; the product is being recalled because of customer complaints ... Class III Acella Pharmaceuticals, LLC
Nov 14, 2022 Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 1... Labeling: Not elsewhere classified; the product is being recalled because of customer complaints ... Class III Acella Pharmaceuticals, LLC
Nov 14, 2022 Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleans... Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period. Class III Acella Pharmaceuticals, LLC
Apr 29, 2021 NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-coun... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Apr 29, 2021 NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx ... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Apr 29, 2021 NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Apr 29, 2021 NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-coun... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Apr 29, 2021 NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-coun... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Sep 17, 2020 NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx O... Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot... Class I Acella Pharmaceuticals, LLC
Sep 17, 2020 NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx On... Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levot... Class I Acella Pharmaceuticals, LLC
May 22, 2020 NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles... Superpotent Drug. Class I Acella Pharmaceuticals, LLC
May 22, 2020 NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx... Superpotent Drug. Class I Acella Pharmaceuticals, LLC
May 22, 2020 NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx O... Superpotent Drug. Class I Acella Pharmaceuticals, LLC

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.