FDA drug recalls

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.

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.

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.

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.

Taro Pharmaceuticals is recalling one lot of fluocinonide 0.05% cream due to a manufacturing defect. Testing found the cream's thickness was thicker than specifications allow, which could affect how the medication works on your skin.

Payless Compounders is recalling a compounded semaglutide injection due to lack of assurance of sterility. The affected product is a 0.5 mL vial from lot 01-27-2026@14S.5 distributed in Oregon. No injuries have been reported so far.

The FDA inspected the manufacturing facility for QC Quality Choice menthol cough drops on August 15, 2025, and found observations that may affect product quality. The company is recalling one lot of vanilla honey flavor cough drops sold nationwide.

QC Quality Choice menthol cough drops are being recalled because the FDA found quality concerns during an inspection of the manufacturing facility on August 15, 2025. The recall affects specific lot numbers with expiration dates in May and July 2026. No injuries have been reported.

QC Quality Choice Menthol-Cough Suppressant Oral Anesthetic Cough Drops in Honey Lemon flavor are being recalled because the FDA found quality concerns during an inspection of the manufacturing facility in August 2025. The affected product is the 30-count bag with lot number 20240720 and expiration date 07/20/2026.

QC Quality Choice Pectin Oral Demulcent Throat Soothing Drops (Creamy Strawberry, 30-count) are being recalled due to manufacturing quality issues found during an FDA inspection. The recall affects lot #20240720 with an expiration date of 07/20/2026, distributed nationwide.

The FDA inspected the manufacturing facility for QC Quality Choice Menthol-Cough Suppressant Oral Anesthetic Cough Drops on August 15, 2025, and identified quality concerns. The recall affects specific lots distributed nationwide. No injuries have been reported.

The FDA inspected the manufacturing facility for QC Quality Choice menthol cough drops on August 15, 2025, and found quality concerns. The company is recalling cherry-flavored cough drops from two specific production batches out of an abundance of caution.

QC Quality Choice menthol cough drops (black cherry flavor, sugar free) are being recalled because the FDA found quality control issues during a factory inspection on August 15, 2025. The specific concern affects lot #20240720 with expiration date 07/20/2026. No injuries have been reported.

MGC Health Menthol Cough Drops (Honey Lemon flavor, 80-count bags) are being recalled because the FDA found quality concerns during an inspection of the manufacturing facility on August 15, 2025. The recall affects lot #20240730 with an expiration date of July 30, 2026, distributed nationwide.

MGC Health Menthol Cough Drops (Honey Lemon flavor, 30-count bags) are being recalled after the FDA found quality concerns during an inspection of the manufacturing facility on August 15, 2025. The recall affects products with lot number 20240524 and expiration date 05/24/2026 distributed nationwide.