Drug recalls
FDA enforcement reports from the last 60 months · Class I is the most serious. Type in the filter box to search, click a column to sort, or toggle whether bulk API / for-further-processing products are included.
ⓘ How this was built
Data sources
- openFDA drug enforcement reports (FDA)
Method
Rows are FDA's own enforcement records, ingested daily; classifications and dates are FDA's. Filtering and counting only — no modeling.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
| III | — D-0740-2026 | Central Admixture Pharmacy Services Inc | Incorrect Product Formulation | Jul 16, 2026 | Ongoing |
| III | D-0737-2026 D-0737-2026 | Ascend Laboratories, LLC | Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12… | Jul 16, 2026 | Ongoing |
| III | D-0739-2026 D-0739-2026 | Ascend Laboratories, LLC | Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12… | Jul 16, 2026 | Ongoing |
| III | D-0738-2026 D-0738-2026 | Ascend Laboratories, LLC | Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12… | Jul 16, 2026 | Ongoing |
| III | Lidolog Kit D-0713-2026 | Asclemed USA Inc. | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | Jul 15, 2026 | Ongoing |
| III | D-0758-2026 D-0758-2026 | Supernus Pharmaceuticals, Inc. | Failed Dissolution Specifications | Jul 6, 2026 | Ongoing |
| III | D-0735-2026 D-0735-2026 | Ascend Laboratories, LLC | Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and T… | Jun 30, 2026 | Ongoing |
| III | D-0736-2026 D-0736-2026 | Ascend Laboratories, LLC | Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and T… | Jun 30, 2026 | Ongoing |
| III | Primidone D-0585-2026 | Amneal Pharmaceuticals, LLC | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. | Jun 3, 2026 | Ongoing |
| III | Hydroxyzine Hydrochloride D-0619-2026 | ANI Pharmaceuticals, Inc. | Presence of foreign substance | Jun 2, 2026 | Ongoing |
| III | — D-0654-2026 | SUN PHARMACEUTICAL INDUSTRIES INC | Failed Impurities/Degradation Specifications | Jun 1, 2026 | Ongoing |
| III | Focalin XR D-0608-2026 | Sandoz Inc | Labeling: Incorrect or Missing Lot and/or Exp Date | Jun 1, 2026 | Ongoing |
| III | Lidolog Kit D-0552-2026 | Eugia US LLC | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | May 18, 2026 | Ongoing |
| III | Pred Mild D-0551-2026 | AbbVie Inc. | Failed Stability Specifications | May 18, 2026 | Ongoing |
| III | D-0581-2026 D-0581-2026 | Fresenius Kabi USA, LLC | Failed Impurities/Degradations Specifications | May 14, 2026 | Ongoing |
| III | Nicotine D-0550-2026 | AVEVA Drug Delivery Systems, Inc. | Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of i… | May 14, 2026 | Ongoing |
| III | Busulfan D-0539-2026 | Sagent Pharmaceuticals | Failed Impurities/Degradation Specifications | May 4, 2026 | Ongoing |
| III | D-0537-2026 D-0537-2026 | Amerisource Health Services LLC | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | May 1, 2026 | Ongoing |
| III | D-0536-2026 D-0536-2026 | Amerisource Health Services LLC | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | May 1, 2026 | Ongoing |
| III | Primidone D-0534-2026 | Golden State Medical Supply Inc. | Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. | Apr 27, 2026 | Ongoing |
Source: FDA drug enforcement reports (openFDA) · showing 20 of 386 recalls