Category
FDA recalls of prescription and over-the-counter drugs.
FDA drug recalls cover prescription medicines, over-the-counter products, biologic and gene therapies, and active pharmaceutical ingredients (the raw drug substances that manufacturers compound into finished products). Recall classifications follow the same Class I / II / III system as food, and most published recalls are Class II — the product is unlikely to cause permanent harm but doesn't meet specification.
The most common reasons for a drug recall are out-of-specification potency or dissolution (the active ingredient is present in too high or too low a dose), microbial contamination, particulate matter in injectables, mix-ups during packaging where bottles end up with the wrong tablets, and nitrosamine impurities in certain drug classes. Many drug recalls are at the lot level — the manufacturer's whole product line is still safe to use, but specific production lots are pulled.
If a recall affects your medication: don't stop taking it on your own. Call your prescriber or pharmacist before doing anything. Stopping a prescribed drug abruptly can be more dangerous than the issue prompting the recall. Most drug-recall remedies route through the dispensing pharmacy, who'll either swap your supply for an unaffected lot or coordinate a refund with the manufacturer.
Padagis US LLC is recalling 43,238 cartons of Evamist (Estradiol) transdermal spray nationwide because the spray content uniformity specification for standard deviation was not met at the 18-month stability time point.
Zydus Pharmaceuticals is recalling certain batches of Colchicine Tablets 0.6 mg because quality testing detected out-of-specification levels of Beta-lumicolchicine impurity. Affected lots were distributed in Arizona, Ohio, and Mississippi.
Pfizer is recalling Nurtec® ODT (rimegepant) 75mg tablets because the blister card packaging is not child-resistant as required by law, posing a poisoning risk to children who may access and swallow the contents.
Snowy Range Blue hand sanitizer is recalled due to FDA findings of methanol, acetaldehyde, and acetal above permissible limits. The product was distributed nationwide across all lot codes.
Pharmedica USA recalled Purely Soothing 15% MSM Drops nationwide due to non-sterility concerns. The voluntary Class I recall affects approximately 1,904 bottles distributed via e-commerce and trade shows.
Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.
Apotex Corp. is recalling Brimonidine Tartrate eye drops (67,056 bottles nationwide) because cracks in bottle caps may compromise sterility and expose patients to contamination.
Nutraceutical Corporation is recalling NaturalCare bioAllers homeopathic liquid drops nationwide due to a raw material manufacturing quality issue. The recall affects lot 222076 with an expiration date of 03/27.
Denver Solutions recalls 8,136 units of Phenylephrine HCl IV solution nationwide due to manufacturing practice deviations. The FDA classified this Class II recall as affecting prescription injectable solutions distributed to hospitals and government facilities.
Amerisource Health Services LLC is recalling 422 cartons of Verapamil Hydrochloride Extended-Release Tablets, 120 mg due to failed dissolution testing. The tablets did not meet specifications for drug release.
Teva Pharmaceuticals is recalling Metformin hydrochloride Extended-Release Tablets (1000 mg) due to CGMP deviations that resulted in NDMA contamination exceeding the Acceptable Daily Intake Limit. The recall affects 12,044 bottles distributed in California.
B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection (Lot J2C017) due to subpotent anti-Factor IIa activity, which may reduce anticoagulant effectiveness.
Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray (0.8 FL Oz) lot 222016 due to manufacturing deviations and product discoloration. The product was distributed nationwide.
Denver Solutions is recalling 325,300 units of Phenylephrine HCl injection due to Current Good Manufacturing Practice deviations. The product was distributed nationwide, including to government facilities.
Phenylephrine HCl syringe recalled for manufacturing practice deviations. 13,445 units distributed nationwide were recalled by Denver Solutions, LLC.
Ecometics, Inc. is recalling Nose Better Gel nationwide due to manufacturing process deviations (CGMP violations). The firm-initiated voluntary recall affects 37,968 units with lot number 1E253A.
Sagent Pharmaceuticals is recalling 28,875 vials of Heparin Sodium Injection nationwide due to a labeling issue. Healthcare providers should verify patient medication before administration.
Ecometics, Inc. has voluntarily recalled Unguentine Original Ointment for Burns due to manufacturing practice deviations. The recall affects 20,746 units distributed nationwide.
Ecometics, Inc. recalled Soltice Quick-RUB nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This was a voluntary recall initiated by the manufacturer in February 2023.
Activator Concentrate, a sodium fluoride oral rinse manufactured by Ecometics, Inc., was voluntarily recalled due to manufacturing practice deviations. The recall affected 34,320 bottles distributed nationwide.
Unguentine Original Pain Relief Ointment is being recalled due to manufacturing process deviations. The FDA-led voluntary recall affects nationwide distribution.
Ecometics, Inc. is voluntarily recalling Vencedor medicated balm (capsaicin 0.028%) nationwide due to manufacturing process deviations. The recall affects Lot #2E021A with expiration date January 2025.
Pharmedica USA is recalling Purely Soothing MSM Nasal Spray (15%, Lot #1808051) due to manufacturing practice violations. The recall affects 995 bottles distributed nationwide and internationally.
Akron Pharma is recalling Dibucaine 1% Hemorrhoidal Ointment due to incorrect or missing lot and expiration date information on the label. This labeling error affects 4,416 tubes distributed nationwide.
Nutraceutical Corporation is recalling NaturalCare children's homeopathic allergy drops (Lot 222148) nationwide due to a manufacturing deviation in raw materials. No illnesses have been reported.
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