Drug and pharmaceutical recalls

Zydus Pharmaceuticals is recalling erythromycin 500 mg tablets because testing found a chemical impurity (N-Nitroso-Desmethyl-Erythromycin) at levels higher than FDA's recommended safe intake limit. The impurity resulted from manufacturing process deviations at the maker in India. No injuries have been reported.

Zydus Pharmaceuticals is recalling erythromycin tablets (250 mg) due to the presence of N-Nitroso-Desmethyl-Erythromycin, a nitrosamine impurity, at levels above the FDA's acceptable intake limit. The affected bottles were distributed nationwide. This impurity can potentially increase cancer risk with long-term exposure.

ANI Pharmaceuticals is recalling estradiol gel (0.1%, 0.25 mg packets) because some packets in affected cartons were found to be empty or only partially filled. This could mean patients receive less medication than prescribed. The recall affects carton lot M251109, which expires in November 2027.

Gas-X Simethicone 125 mg softgels distributed by Haleon are being recalled because the carton labeling does not list all inactive ingredients. This affects three specific lot codes (KB5Y, MP4B, and SS4F) distributed nationwide.

Lupin Pharmaceuticals is recalling certain batches of Liraglutide Injection (a diabetes and weight-loss medication) because white thread-like particles have been found inside the cartridges. The affected pens are distributed nationwide. No injuries have been reported.

Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications. The affected lots are 656412 (expiring 08/31/2026) and 659646 (expiring 03/31/2027). This is a prescription medication used in cancer treatment.

Safecor Health distributed atomoxetine 25 mg capsules that were labeled as 10 mg capsules. This labeling error affects one lot distributed in Texas. The mislabeling could result in patients taking a higher dose than prescribed.

Amerisource Health Services has recalled certain batches of Primidone Tablets, USP, 50 mg due to cross-contamination during manufacturing. The tablets contain trace amounts of Acemetacin, a different active pharmaceutical ingredient, which should not be present in this medication.

Primidone tablets distributed by American Health Packaging were found to contain trace amounts of Acemetacin, a different active pharmaceutical ingredient, due to cross-contamination during manufacturing. The affected lot (1027583, expiring 09/30/2027) contains approximately 63,500 tablets distributed nationwide. No injuries have been reported.

Golden State Medical Supply's Primidone Tablets (250 mg) contain trace amounts of Acemetacin, a different medication, due to cross-contamination during manufacturing. This affects two lots distributed nationwide. No injuries have been reported.

Golden State Medical Supply is recalling Primidone 50 mg tablets because the active ingredient was contaminated with trace amounts of Acemetacin, a different medication. This contamination occurred during manufacturing. The affected bottles are identified by specific lot numbers with expiration dates in 2028.

Lannett Company's Primidone Tablets 250mg were contaminated during manufacturing with trace amounts of Acemetacin, a different active pharmaceutical ingredient. The contamination affected specific lot numbers distributed nationwide. No injuries have been reported.

JXK Enterprises is recalling Boner Bears Chocolate (Lot #BB21125) because FDA testing found sildenafil, the active ingredient in prescription Viagra, in the product—but it was not listed on the label. Sildenafil can cause serious interactions with certain heart and blood pressure medications and poses health risks for people with diabetes, high blood pressure, or heart disease.

Ascend Laboratories is recalling one lot of metoprolol succinate extended-release 25 mg tablets because they failed to meet dissolution specifications. This means the tablets may not break down and release the medication properly in the body. The affected lot was distributed nationwide.

Endo USA is recalling certain batches of buprenorphine hydrochloride 0.3 mg/mL injection due to the presence of particulate matter identified as buprenorphine free base in the vials. The affected lots are 84132 (expiration 02/28/2027) and 87693 (expiration 03/31/2027). No injuries have been reported.

Oasis Medical is recalling specific lots of Oasis Tears PF preservative-free eye drops because the FDA found concerns about sterility assurance during an inspection. No injuries have been reported, but the company is recalling the product out of caution.

Sun Pharmaceutical is recalling one batch of Aisling doxorubicin hydrochloride liposome injection (a cancer medication) because glass particles were found in some vials during manufacturing. Glass particles in injectable medications can cause local tissue damage, blood vessel blockage, or blood clots if injected into the bloodstream. No patient injuries have been reported so far.

Pharmacal recalled one lot of MG217 Multi-Symptom Treatment Cream & Skin Protectant Eczema Cream (6oz tube, lot 1024088) because it was found to contain Staphylococcus aureus bacteria. The contaminated product could cause infections ranging from localized skin infections to serious conditions like sepsis, especially in people with weakened immune systems or compromised skin. No illnesses have been reported so far.

Teva Pharmaceuticals is recalling specific lots of Claravis (isotretinoin) 10 mg capsules because they contain higher-than-allowed levels of tretinoin, a related chemical impurity. The affected lots are 100067507 and 100067508, which expire on July 31, 2026. No injuries have been reported so far.

B. Braun Medical is recalling two lots of Lactated Ringer's Injection (1L, product code E7500) because the solution contains unwanted particles, including cellulose and stearates. If these particles enter a patient's bloodstream during use, they could cause serious complications including blood clots, tissue damage, or organ failure.

Avantor Performance Materials has recalled Magnesium Chloride, 6-Hydrate Crystal (500G bottles, Lot 23G3161005, expiration 9/21/2027) because the product does not meet strength specifications. This bulk pharmaceutical ingredient may be less potent than labeled.

Island Kinetics, Inc. (d.b.a. CoValence Laboratories) is recalling specific lots of Skin Script Blemish Spot Treatment because the product failed stability testing. This means the product may not maintain its intended strength or safety over time. No injuries have been reported.

Major Pharmaceuticals is recalling memantine hydrochloride extended-release 7 mg capsules (lot N02425, expiring 05/31/2027) because the capsules may not dissolve properly in the body. This means the medication may not work as intended. The affected capsules were distributed nationwide.

International Medication Systems Ltd. is recalling one lot of epinephrine injection due to concerns that the sterility of the product cannot be assured. The affected lot (EA038A5, expiring 08/2026) was distributed nationwide. No injuries have been reported.

Island Kinetics' Essential Calming Skin Gel containing hydrocortisone 1% may contain less active ingredient than labeled. This affects lot 4212D4 with an expiration date of 07/31/2026. The product was distributed nationwide.

Island Kinetics' Skin Rehab Calming Skin Gel with Hydrocortisone 1% (Lot 4212D2, expires 07/03/2026) does not contain the correct amount of active ingredient. The product is weaker than labeled and may not work as intended for skin inflammation or itching.

Remedy Gel, a hydrocortisone 1% topical treatment distributed by glo Skin Beauty, contains less active ingredient than labeled. Affected bottles (lots 4155D2 and 4155D3, expiring 05/15/2026) may not provide the expected therapeutic effect. No injuries have been reported.

Nephron SC is recalling albuterol sulfate inhalation solution (0.5%, 30x5 mL vials, Lot AB6001, expiring 1/15/2027) because the labels are illegible and cannot be read clearly. This makes it difficult to verify the correct dose and medication details. The recall affects 146,280 vials distributed nationwide.

Taro Pharmaceuticals is recalling one lot of fluocinonide 0.05% cream due to viscosity testing that showed the cream is thicker than the approved specification. This may affect how the medication spreads and absorbs. No injuries have been reported.

Taro Pharmaceuticals is recalling Fluocinonide 0.05% Cream (30g tubes, Lot AD76251, expiring 6/30/2026) because the product's thickness is outside the acceptable range. This was discovered during stability testing. The thicker-than-normal cream may affect how well it spreads and works on skin.