FDA drug recalls
Formal FDA enforcement reports for prescription and over-the-counter drugs — contamination, wrong potency, mislabeling, and manufacturing failures.
768 recalls in the last 12 months, translated into plain English.
- 2026-03-04AgeboxClass IIStop using Agebox iKids-Growth capsules
Agebox iKids-Growth Day Formula capsules contain an undeclared drug ingredient called ibutamoren that was not approved by the FDA. The product was sold without proper FDA authorization. This affects 60-count bottles with lot numbers 23101201, 24080801, and 25020701.
- 2026-03-04Slate Run PharmaceuticalsClass IIICheck Slate Run Eptifibatide Injection labeling
Slate Run Pharmaceuticals is recalling Eptifibatide Injection 75 mg/100 mL vials because the carton label says "weight-adjusted bolus dosing" when it should say "weight-adjusted infusion." This labeling error could lead to incorrect administration of the medication. No injuries have been reported.
- 2026-03-04AvKAREClass IIStop using AvKARE Amantadine HCl capsules
AvKARE is recalling one lot of Amantadine HCl 100 mg capsules because they failed to meet dissolution specifications—meaning the capsules may not break down properly in the body, affecting how much medicine you receive. This is a quality issue identified during manufacturing testing. No injuries have been reported.
- 2026-03-04Leo PharmaClass IIStop using recalled Adbry injection lots
LEO Pharma is recalling specific lots of Adbry, a prescription injection used to treat atopic dermatitis, because one unit was found to contain wool fiber particles. This contamination raises concerns about sterility and safety. No injuries have been reported so far.
- 2026-02-18McKessonClass ICheck your UDENYCA injection lot and serial number
McKesson's UDENYCA (pegfilgrastim-cbqv) injection was stored at room temperature instead of in the refrigerator, which may have reduced its effectiveness. This affected 116 cartons from Lot 2199821 with specific serial numbers. The FDA classified this as a Class I recall.
- 2026-02-18Meitheal PharmaceuticalsClass IIStop using Meitheal Cetrorelix Acetate injection kits
Meitheal Pharmaceuticals is recalling Cetrorelix Acetate 0.25 mg injection kits because some contain missing or duplicated needles in the delivery system. This affects lot Q4E0112A with an expiration date of April 30, 2027. The defect could prevent proper injection or cause unsafe handling.
- 2026-02-18AmerisourceClass IICheck your oxycodone tablets for loose packaging
American Health Packaging is recalling certain oxycodone hydrochloride 5 mg tablets because the blister card seals are defective or missing. This allows tablets to fall out of their compartments. The recall affects 31,676 packages distributed nationwide with specific lot numbers and expiration dates.
- 2026-02-18Fresenius KabiClass IIStop using recalled Fresenius Kabi vancomycin injection
Fresenius Kabi Compounding has recalled vancomycin HCl 2-gram doses mixed in sodium chloride solution due to concerns that sterility cannot be assured. The affected lots were distributed nationwide. This is a serious issue because non-sterile injectables can cause life-threatening infections.
- 2026-02-18Fresenius KabiClass IIStop using Fresenius Kabi vancomycin HCl IV bags
Fresenius Kabi Compounding issued a recall of vancomycin HCl 1.5 grams in 500 mL sodium chloride solution due to lack of assured sterility. The affected lot (C274-000049628, expiring May 3, 2026) was distributed nationwide to healthcare facilities. No injuries have been reported.
- 2026-02-18Fresenius KabiClass IIDo not use Fresenius Kabi thiamine HCl injection
Fresenius Kabi Compounding has recalled multiple lots of thiamine HCl 500 mg injection because the manufacturer cannot confirm the product is sterile. This injectable medication was distributed nationwide. The recall affects 10,548 bags with expiration dates between February and May 2026.
- 2026-02-18Fresenius KabiClass IIDo not use Fresenius Kabi ketamine HCl injection
Fresenius Kabi Compounding has recalled five specific lots of ketamine HCl injection (10 mg per mL) distributed nationwide because the manufacturer cannot confirm the product remains sterile. The affected lots were produced between February and April 2026.
- 2026-02-18Fresenius KabiClass IIDo not use Fresenius Kabi acyclovir sodium IV bags
Fresenius Kabi Compounding has recalled acyclovir sodium 200 mg IV injection bags because the manufacturer cannot guarantee the product is sterile. The affected bags were produced by Fagron Sterile Services and have lot number C274-000049124 with an expiration date of February 28, 2026. No infections or injuries have been reported so far.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health is recalling specific lots of testosterone 100mg/anastrozole 4mg sterile pellets due to potential metal particulate matter in the product. The contamination was discovered during quality testing. No injuries have been reported.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health has recalled a specific lot of testosterone and triamcinolone acetonide pellets because they may contain metal particulate matter. This contamination was discovered during manufacturing. The affected lot is 256000103, which expires July 28, 2026.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health hormone pellets
Asteria Health is recalling a hormone medication pellet containing testosterone and triamcinolone due to the potential presence of metal particulate matter in the product. The recall affects lot 256000105 with an expiration date of September 19, 2026, distributed nationwide. No injuries have been reported.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health hormone pellets
Asteria Health is recalling a testosterone and triamcinolone acetonide combination pellet due to the potential presence of metal particulate matter in the product. The recall affects lot #256000104 with an expiration date of 07/30/2026, distributed nationwide. No injuries have been reported.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health is recalling specific lots of testosterone 75mg/anastrozole 4mg sterile pellets due to potential metal particulate matter found in the product. The affected lots were distributed nationwide. No injuries have been reported.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health is recalling one lot of testosterone 100mg/anastrozole 4mg pellets because they may contain metal particles. The affected lot (254000104, expiring 05/27/2026) was distributed nationwide. No injuries have been reported.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health testosterone pellets (303 mg) may contain metal particulate matter that could contaminate the product. The recall affects 1,015 pellets from lot #251000124 with an expiration date of 06/02/2026 distributed nationwide. No injuries have been reported.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health testosterone pellets (200 mg) may contain metal particulate matter due to a manufacturing issue. The FDA has classified this as a Class II recall affecting multiple lot numbers distributed nationwide. No injuries have been reported to date.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health is recalling certain testosterone pellet injections because they may contain metal particulate matter. The contamination was identified in seven specific manufacturing lots with expiration dates between June 2026 and September 2026. No injuries have been reported so far.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health is recalling testosterone pellets (87.5 mg) because they may contain metal particles. The recall affects three specific lots distributed nationwide. No injuries have been reported so far.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health testosterone pellets (62.5 mg) may contain metal particulate matter. The affected lot (251000125, expiring 06/02/2026) was distributed nationwide. About 1,758 pellets are involved in this recall.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health testosterone pellets may contain metal particulate matter as a result of a manufacturing issue. The recall affects specific lot numbers distributed nationwide. No injuries have been reported to date.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health's testosterone pellets may contain metal particulate matter due to a manufacturing issue. The FDA has identified five affected lot numbers distributed nationwide. No injuries have been reported.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health testosterone pellets (25 mg) may contain metal particulate matter due to a manufacturing issue. The FDA has classified this as a Class II recall affecting multiple lot numbers distributed nationwide. No injuries have been reported to date.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health is recalling testosterone pellets (18.0 mg, lot #251000126, expiring 06/03/2026) because they may contain metal particulate matter. The recall affects 146 pellets distributed nationwide. No injuries have been reported.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health testosterone pellets
Asteria Health testosterone pellets (12.5 mg) may contain metal particulate matter due to a manufacturing issue. The recall affects specific lots distributed nationwide. No injuries have been reported to date.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health estradiol pellets
Asteria Health's estradiol 37.5 mg sterile pellets may contain metal particulate matter. This affects lot 253000125, expiring 06/09/2026. No injuries have been reported to date.
- 2026-02-18Asteria HealthClass IIStop using Asteria Health estradiol pellets
Asteria Health estradiol 25 mg pellets may contain metal particulate matter. The affected lot (253000136, expiring 07/01/2026) was distributed nationwide. No injuries have been reported.
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