[ FDA ENFORCEMENT INTELLIGENCE ]
Learn from the record. Every FDA recall is a quality signal.
Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.
1,000
Total recalls
217
Class I (most serious)
167
Drug
515
Device
318
Food / supplement / cosmetic
Last 12 months · latest report 2026-07-22 · source: openFDA enforcement
RECALLS BY CLASSIFICATION · MONTHLY
RECALL REASONS BY QUALITY DOMAIN
Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.
839 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-06-24 | Class II | Dabur India LimitedD-0641-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
| 2026-06-24 | Class II | PAI Holdings LLCD-0591-2026 | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | Validation & Qualification |
| 2026-06-24 | Class II | PAI Holdings LLCD-0592-2026 | Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 | Validation & Qualification |
| 2026-06-24 | Class II | Dabur India LimitedD-0635-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
| 2026-06-24 | Class II | Dabur India LimitedD-0631-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
| 2026-06-24 | Class III | Sandoz IncD-0608-2026 | Labeling: Incorrect or Missing Lot and/or Exp Date | Documentation & Change Control |
| 2026-06-24 | Class II | Dabur India LimitedD-0640-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
| 2026-06-24 | Class II | Dabur India LimitedD-0633-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
| 2026-06-17 | Class III | Amneal Pharmaceuticals, LLCD-0585-2026 | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. | Environmental Monitoring |
| 2026-06-17 | Class I | SUN PHARMACEUTICAL INDUSTRIES INCD-0580-2026 | Presence of Particulate matter: Particulate matter identified as glass. | Environmental Monitoring |
| 2026-06-17 | Class II | Breckenridge Pharmaceutical, Inc.D-0582-2026 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Validation & Qualification |
| 2026-06-17 | Class III | Fresenius Kabi USA, LLCD-0581-2026 | Failed Impurities/Degradations Specifications | Validation & Qualification |
| 2026-06-17 | Class I | Haleon US Holdings LLCD-0595-2026 | Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. | Environmental Monitoring |
| 2026-06-17 | Class II | Golden State Medical Supply Inc.D-0587-2026 | Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint. | Validation & Qualification |
| 2026-06-17 | Class II | Zep IncD-0586-2026 | Microbial contamination of sterile products | Environmental Monitoring |
| 2026-06-17 | Class I | BEEKEEPER'S NATURALS USA INC.D-0620-2026 | Microbial Contamination of Non-Sterile Products | Environmental Monitoring |
| 2026-06-17 | Class II | Ascend Laboratories, LLCD-0597-2026 | Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis | Validation & Qualification |
| 2026-06-17 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0607-2026 | Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution | — |
| 2026-06-17 | Class II | Breckenridge Pharmaceutical, Inc.D-0583-2026 | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Validation & Qualification |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0576-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0563-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | SUN PHARMACEUTICAL INDUSTRIES INCD-0598-2026 | Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by FDA of marketing the product under the proprietary name Xyvona | Documentation & Change Control |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0564-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0557-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
| 2026-06-10 | Class II | Guardian Drug Co. Inc.D-0567-2026 | Presence of foreign substance: small metallic particles in chewable tablets. | — |
Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.