FDA drug recalls

Vitruvias Therapeutics is recalling Thyroid Tablets, USP 1/2 Grain (30 mg) because the tablets are superpotent—meaning they contain higher-than-intended levels of active ingredients. This lot was distributed nationwide. The affected lot number is 504950, expiring 09/30/2026.

Pfizer has recalled one lot of Dopamine HCl injection (40 mg/mL) distributed nationwide due to a lack of assurance of sterility. The affected lot is NL5230, with an expiration date of October 2027. This is a precautionary measure to ensure patient safety.

Inventia Healthcare Limited's chlorthalidone 25 mg tablets (batch RISA24002, expiring 04/2027) failed to meet dissolution specifications, meaning the tablets may not break down properly in the body. This could affect how well the medication works. About 13,567 bottles were distributed nationwide.

Taro Pharmaceuticals is recalling one lot of Lidocaine Ointment USP 5% because testing found the active ingredient strength was outside acceptable limits. The affected lot was identified during long-term stability testing. No injuries have been reported.

Safecor Health is recalling specific lots of Fluphenazine HCl Elixir 20 mg per 4 mL because they failed to meet stability specifications — meaning the medication may not remain safe and effective until its printed expiration date. The affected lots were distributed nationwide.

Safecor Health is recalling Fluphenazine HCl Elixir (15 mg per 3 mL) in four specific lots because the medication failed to meet stability test requirements. This means the drug may not remain safe and effective through its expiration date. The affected lots were distributed nationwide.

Safecor Health is recalling specific lots of Fluphenazine HCl Elixir 10 mg per 2 mL because they failed stability testing. This means the medication may not maintain its strength or safety over time. The recall affects 11 lots distributed nationwide.

Safecor Health is recalling specific lots of Fluphenazine HCl Elixir 5 mg per 10 mL because they failed stability testing requirements. The affected lots may not maintain their expected strength and safety over their labeled shelf life. This medication is used to treat certain psychiatric conditions.

Safecor Health is recalling multiple lots of Fluphenazine HCl Elixir (5 mg per 1 mL) because the medication failed to meet stability specifications. This means the drug's strength, purity, or safety characteristics may not be reliable. The recall affects 19 lots distributed nationwide.

Safecor Health is recalling specific lots of Fluphenazine HCl Elixir 2.5 mg per 5 mL because they failed stability testing, meaning the medication may not maintain its strength or safety over time. The affected lots were distributed nationwide.

Sun Pharmaceutical is recalling specific lots of Nystatin Cream, USP (15 g tubes) because the medication failed stability testing. This means the cream may not maintain its expected strength or safety over time. The affected lots are AD49605 and AD49606, with expiration dates of 05/31/2027.

B. Braun Medical Inc. is recalling specific lots of 0.9% Sodium Chloride Injection due to the presence of particulate matter, including iron oxide, inorganic material, cellulose fibers, and polystyrene. The contamination was identified during quality testing. This is a sterile injectable product distributed nationwide.

American Regent's epinephrine injection (1 mg/mL, 30 mL vials) may contain particulate matter—including nylon, glass, and other materials—and some vials are broken or leaking. This affects the sterility and safety of the medication. Three specific lot numbers distributed nationwide are involved.

OurPharma LLC's fentanyl citrate 1,000 mcg injection solution has conflicting expiration dates printed on the IV bag and product labeling. The bag shows expiry dates of 07/31/2026 or 11/30/2026, while the product itself is labeled as expiring 12/09/2026. This discrepancy could lead to confusion about when the medication is safe to use.

Baxter Healthcare identified stainless steel particles in certain 2000 mL bags of Dextrose Injection, USP 70%. The contamination affected 606 bags (Lot #Y495066, expiration July 31, 2027) distributed nationwide. No injuries have been reported.

Ajanta Pharma USA Inc. is recalling fluphenazine hydrochloride 1mg tablets (NDC 27241-255-01) because stability testing at 18 months found organic impurity levels slightly above specification limits. The tablets contained 1.1% of Impurity-A, exceeding the 1.0% specification. No injuries have been reported.

ImprimisRx NJ LLC is recalling specific lots of Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution used in medical offices because the medication contains lower-than-intended active ingredients. The affected lots may not work as intended for their intended use.

Optimal Balance Pharmacy's Glutathione 200 mg/mL injectable solution failed quality testing and was found to contain bacterial endotoxin levels above safe limits. This contamination poses a risk of serious infection or systemic reaction when injected. The affected lot (LG342009076) was distributed nationwide.

Baxter Healthcare Corporation is recalling 0.9% Sodium Chloride Injection USP in 500 mL VIAFLEX plastic containers because some bags contain fiberglass particles. The affected lots are Y495523 and Y495523A, expiring October 31, 2027. No injuries have been reported.

Golden State Medical Supply Inc. is recalling one lot of Prasugrel HCI 10mg tablets because they failed to meet dissolution specifications—meaning the tablets may not break down properly in the body and release the medication as intended. This could affect how well the medication works. The recall affects lot #GS062298 with an expiration date of 09/30/2026.

American Health Packaging distributed buprenorphine sublingual tablets with incorrect labeling. The affected medication is a prescription opioid used to treat pain and opioid use disorder. A label mix-up could result in dosing errors if patients or healthcare providers rely on incorrect information.

Mylan Pharmaceuticals is recalling Prasugrel 10mg tablets (Lot #3225272, expiring September 30, 2026) because they failed dissolution testing during 18-month stability studies. This means the tablets may not break down and release the medication as intended in the body. No injuries have been reported.

Chiesi USA, Inc. is recalling Revcovi (elapegademase-lvlr) Injection due to out-of-specification stability results in the protein concentration profile. The affected lot was distributed to Missouri and Tennessee. No injuries have been reported.

Sage Products is recalling specific lots of 2% Chlorhexidine Gluconate non-sterile cloths due to potential cross-contamination with other products during manufacturing. The affected cloths may not meet safety and quality standards. No injuries have been reported.

Teva Pharmaceuticals discovered that some bottles of trazodone 50 mg tablets contain foreign tablets or capsules mixed in with the correct medication. The issue affects one lot (1394026) with an expiration date of February 2028. No injuries have been reported.

Supernus Pharmaceuticals is recalling one lot of Trokendi XR (topiramate) 50 mg extended-release capsules because the medication did not dissolve as designed. When a medication fails to dissolve properly, the body may not absorb the full dose, potentially reducing its effectiveness.

Mylan Pharmaceuticals is recalling specific lots of Mycophenolate Mofetil for injection (500 mg/vial) because the medication failed to meet dissolution specifications—meaning the drug may not dissolve properly in the body. This could affect how well the medicine works. The recall affects two lots distributed nationwide.

Broadway Joe's Pain Cream (3000 mg CBD, 4 oz jar) is being recalled due to potential contamination of raw materials used to make the product. The affected lots were distributed in Colorado. No injuries have been reported.

Broadway Joe's Pain Cream (2 oz jar) is being recalled due to potential contamination of raw materials used in production. The recall affects specific lots distributed in Colorado. No injuries have been reported.

Testing by Allies Group found that certain batches of The ONE SPF 50 Invisible Sunscreen Gel may not provide the SPF 50 sun protection stated on the label. The affected product was distributed nationwide in the U.S. No injuries have been reported.