Drug and pharmaceutical recalls
754 federal recalls in the last 12 months. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2026-06-24FDA-DrugPAI Holdings LLCClass IIVistaPharm Kerr Insta-Char recalled for quality standards failure
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
- 2026-06-24FDA-DrugPAI Holdings LLCClass IIVistaPharm Kerr Insta-Char recalled for not meeting OTC standards
Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023
- 2026-06-24FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIGlenmark Alyacen 7/7/7 birth control recalled for impurity levels
Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.
- 2026-06-17FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IISun Pharmaceutical budesonide recalled for foreign particles
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
- 2026-06-17FDA-DrugAscend Laboratories, LLCClass IIAscend Minocycline tablets recalled for dissolution failure
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
- 2026-06-17FDA-DrugHaleon US Holdings LLCClass IGas-X Extra Strength recalled for coolant contamination
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
- 2026-06-17FDA-DrugGolden State Medical Supply Inc.Class IIGolden State Medical Supply niacin tablets recalled for dissolution failure
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.
- 2026-06-17FDA-DrugZep IncClass IIZep Alcohol Sanitizer Spray recalled for microbial contamination
Microbial contamination of sterile products
- 2026-06-17FDA-DrugAmneal Pharmaceuticals, LLCClass IIIAmneal Primidone tablets recalled for cross-contamination risk
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- 2026-06-17FDA-DrugBreckenridge Pharmaceutical, Inc.Class IIBreckenridge Duloxetine 60mg recalled for impurity risk
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 2026-06-17FDA-DrugBreckenridge Pharmaceutical, Inc.Class IIBreckenridge Duloxetine capsules recalled for impurity concern
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 2026-06-17FDA-DrugFresenius Kabi USA, LLCClass IIIFresenius Kabi epinephrine injection recalled for impurity concerns
Failed Impurities/Degradations Specifications
- 2026-06-17FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass ISun Pharmaceutical doxorubicin injection recalled for glass particles
Presence of Particulate matter: Particulate matter identified as glass.
- 2026-06-17FDA-DrugBEEKEEPER'S NATURALS USA INC.Not Yet ClassifiedBeekeeper's Naturals nasal spray recalled for microbial contamination
Microbial Contamination of Non-Sterile Products
- 2026-06-11FDA-PRBeekeeper’s NaturalsBeekeeper's Naturals nasal spray recalled for microbial contamination
FOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA - Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp. Date 02/2028 of Beekeeper’s Naturals Saline Nasal Spray, sold only through Amazon, to the consumer level. This lot, produced at a third-party manufacturer, tested above our acceptable
- 2026-06-03FDA-DrugAbbVie Inc.Class IIIAbbVie PRED MILD eye drops recalled for stability issue
Failed Stability Specifications
- 2026-06-03FDA-DrugAVEVA Drug Delivery Systems, Inc.Class IIIAveva nicotine patches recalled for elevated impurities
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
- 2026-05-27FDA-DrugWisconsin Pharmacal CompanyClass IMG217 skin cream recalled for bacterial contamination
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
- 2026-05-27FDA-DrugSafecor Health, LLCClass IISafecor Health Nephronex vitamin supplement recalled for foreign particles
Presence of a Foreign Substance; black particles observed in liquid
- 2026-05-27FDA-DrugIntegraDose Compounding Services LLCClass IIIntegraDose fentanyl citrate injection recalled for subpotency
Subpotent Drug
- 2026-05-27FDA-DrugUCB Biosciences Inc.Class IICimzia prefilled syringes recalled for sterility concerns
Lack of Assurance of Sterility
- 2026-05-27FDA-DrugZydus Pharmaceuticals (USA) IncClass IIZydus erythromycin tablets recalled for nitrosamine impurity
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
- 2026-05-27FDA-DrugZydus Pharmaceuticals (USA) IncClass IIZydus erythromycin tablets recalled for nitrosamine impurity
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
- 2026-05-27FDA-DrugANI Pharmaceuticals, Inc.Class IIANI Pharmaceuticals estradiol gel recalled for defective packets
Defective Container; packets were found to be either empty or partially full.
- 2026-05-27FDA-DrugHaleon US Holdings LLCClass IIGas-X Simethicone recalled for incomplete ingredient labeling
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
- 2026-05-27FDA-DrugLupin Pharmaceuticals Inc.Class IILupin Liraglutide Injection recalled for particulate matter
Presence of particulate matter: a white thread-like structure in the cartridge
- 2026-05-27FDA-DrugSagent PharmaceuticalsClass IIISagent Busulfan Injection recalled for impurity specifications failure
Failed Impurities/Degradation Specifications
- 2026-05-27FDA-DrugSafecor Health, LLCClass IISafecor Health atomoxetine capsules mislabeled with wrong strength
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
- 2026-05-27FDA-DrugAmerisource Health Services LLCClass IIIAmerisource Primidone Tablets recalled for contamination
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- 2026-05-27FDA-DrugAmerisource Health Services LLCClass IIIAmerisource Primidone tablets recalled for cross-contamination
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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