FDA drug recalls

Asteria Health is recalling estradiol 22 mg pellets (Lot# 253000126, expiring 06/09/2026) because they may contain metal particulate matter. The recall affects 133 pellets distributed nationwide. No injuries have been reported.

Asteria Health's estradiol 20 mg hormone pellets may contain metal particulate matter. This affects one specific lot (253000124) with an expiration date of June 2, 2026, distributed nationwide. No injuries have been reported.

Asteria Health is recalling estradiol pellets (18 mg) because some may contain metal particulate matter. The affected lot was distributed nationwide. No injuries have been reported.

Asteria Health estradiol 15 mg pellets may contain metal particulate matter, a foreign substance that could pose a health risk. The FDA has identified four affected lot numbers distributed nationwide. No injuries have been reported to date.

Asteria Health estradiol pellets (12.5 mg) may contain metal particulate matter. The affected lots were distributed nationwide. No injuries have been reported to date.

Asteria Health is recalling estradiol hormone pellets (10 mg) because they may contain metal particles. The affected pellets were distributed nationwide. No injuries have been reported so far.

Presence of Foreign substance - potential presence of metal particulate matter

Unichem Pharmaceuticals distributed 60,000 tablets of Doxazosin 4 mg with incorrect imprinting on the tablets themselves. This labeling error could cause confusion about the medication's identity and strength. The affected lot is GDSH25006, which expires in August 2027.

Pro Numb Tattoo Numbing Spray (4% Lidocaine) in lot J15 was distributed nationwide but did not meet FDA manufacturing standards. The spray may not be safe or effective as a result.

Pro Numb Tattoo Numbing Spray (5% lidocaine) is being recalled due to manufacturing quality control issues. The FDA found that the product was not made under proper conditions. Certain lot numbers (J01–J14 and J55–J69) distributed nationwide may be affected.

Sun Pharmaceutical is recalling one lot of Diclofenac Sodium Topical Gel, 3% (Lot #AD92721, expiring 3/31/2027) because the gel's thickness is slightly lower than required specifications. The product was distributed nationwide and is sold by prescription only.

Rheumacare capsules manufactured by Virgo UAP Pharma in India were found to contain lead due to manufacturing defects. The affected product is a 30-count bottle with lot numbers CAM040 (expires 06/30/2029) or CAL079-N (expires 09/30/2028). Only 4 bottles were distributed to a customer in New York.

Granules Pharmaceuticals is recalling certain bottles of trazodone 50 mg because some bottles may contain foreign tablets or capsules mixed in. This affects 71,424 bottles with batch number 6160008A and an expiration date of 12/31/2026. No injuries have been reported.

Green Lumber Natural Fuel For Men capsules were sold as a supplement but contain tadalafil, a prescription medication approved only for treating erectile dysfunction and certain heart conditions. The product was marketed and sold without FDA approval and without listing tadalafil on the label. Tadalafil can cause serious side effects, especially in people taking certain other medications or with certain health conditions.

Unichem Pharmaceuticals is recalling one lot of bisoprolol fumarate and hydrochlorothiazide tablets (2.5 mg/6.25 mg) because they contain higher-than-allowed levels of N-Nitroso Bisoprolol, a potentially harmful impurity. The affected lot was manufactured in India and distributed nationwide.

Novadoz Pharmaceuticals is recalling specific lots of glycopyrrolate oral solution (1 mg/5 mL) because the medication failed quality testing for impurities and degradation. The affected lots may not meet safety and effectiveness standards. Three lots are involved, with expiration dates between April and May 2027.

Greenstone LLC is recalling methylprednisolone 4 mg Dosepak tablets (Lot #LG7675, expiring November 2026) because the blister foil is oriented incorrectly. This misalignment can make the dosing directions on the foil confusing or unclear, which could lead to taking the wrong dose.

Some bottles of INON ACE antacid tablets are dissolving more slowly than they should in your stomach. This means the medication may not work as intended. The affected bottles were distributed in California and Hawaii.

Some bottles of Parodontax Active Gum Health mouthwash (mint, 16.9 FL OZ) may be missing or have illegible lot and expiration date codes. This makes it impossible to know when the product expires. The affected lot is #0665363 with an expiration date of 08/31/2027.

Baxter Healthcare's Sterile Water for Irrigation 250 mL bottles may contain small plastic particles that came loose from the bottle rim and entered the solution. This affects lot G171359 with an expiration date of 05/31/2027. No injuries have been reported.

Zydus Pharmaceuticals is recalling Icosapent Ethyl 1-gram capsules because some bottles may contain capsules that have lost potency (strength) due to leakage and oxidation. This means the medication may not work as intended. The recall affects specific lot numbers expiring in February and April 2027.

Specialty Process Labs is recalling one lot of Thyroid, USP (an active pharmaceutical ingredient used in manufacturing) because it does not meet strength standards. The affected lot may contain less active ingredient than labeled, which could affect the potency of products made with it.

Rising Pharmaceuticals is recalling Furosemide Tablets, USP 40 mg (a water pill used to treat swelling and high blood pressure) because some bottles may contain a foreign substance. The affected lot is FUB125042G with an expiration date of May 2027. This recall affects 4,212 bottles distributed nationwide.

Cipla USA is recalling Diclofenac Sodium Topical Gel 1% (batch XHBG, expiring 08/31/2027) because it failed to meet required pH specifications during quality testing. The gel may not work as intended or could cause skin irritation. No injuries have been reported so far.

Cipla USA is recalling certain pre-filled syringes of Lanreotide Injection 120 mg because they may contain particulate matter (small particles) in the solution. The affected syringes have specific lot numbers and expiration dates between October 2026 and March 2027. No injuries have been reported so far.

Several Colgate and Crest toothpaste products distributed by Gold Star Distribution Inc. were stored in conditions with rodent exposure and activity. The FDA found insanitary conditions at the distribution center that do not meet manufacturing standards. No injuries have been reported.

Gold Star Distribution Inc. distributed multiple Axe body sprays and Lucky deodorant products that were stored in conditions with rodent activity. The FDA found insanitary handling at their distribution center. No injuries have been reported.

Gold Star Distribution Inc. distributed several petroleum jelly products that were stored in insanitary conditions, including exposure to rodents, at their distribution center. The affected products include Vaseline, Lucky, Personal Care, and Softee petroleum jelly in various sizes and formulations. All lots distributed by Gold Star that have not expired may be affected.

Lucky Ice Cool Mouthwash was distributed from a facility with insanitary conditions, including rodent exposure and activity. The FDA is recalling all unexpired lots of this product due to potential contamination from the distribution center conditions.

Gold Star Distribution's 4 oz vaporizing chest rub was distributed from a facility with insanitary conditions, including rodent exposure. The product may have been contaminated during storage or handling at their distribution center.