Drug and pharmaceutical recalls

Burkhart topical anesthetic gel (benzocaine 20%, strawberry flavor) may contain bottles with incomplete seals, which could allow the product to leak or become contaminated. About 150 units with expiration date 04/15/2029 are affected nationwide.

DHP Topical Anesthetic Gel (Benzocaine 20%, Strawberry Flavor) may contain bottles with incomplete seals that could compromise the integrity of the product. About 150 units with lot number BNZ-001921 and expiration date April 15, 2029 were distributed nationwide.

Quala Dental Products topical anesthetic gel (20% benzocaine, strawberry flavor, 1 oz bottles) may have incomplete seals on some bottles. This could allow the product to leak or become contaminated. The recall affects 150 units distributed nationwide.

Pearson Quality Topical Anesthetic Gel (20% benzocaine, mint flavor) may contain bottles with incomplete seals. The defective containers could allow the product to leak or become contaminated. About 900 units are affected nationwide.

Par Health USA's buprenorphine HCl injection (0.3 mg/mL) has been found to contain crystallization identified as buprenorphine free base in certain lots. This affects vials distributed nationwide. The FDA has classified this as a Class II recall.

Ajanta Pharma USA Inc. distributed bottles labeled as Aripiprazole 30 mg that actually contained Voriconazole 50 mg, a different medication used to treat fungal infections. This mix-up affected 6,143 bottles (Lot PA00805, expiring 01/31/2029) distributed nationwide. The error was discovered and reported to the FDA.

IntegraDose Compounding Services LLC is recalling Vasopressin 2 Units/2 mL syringes because the drug may contain less active ingredient than labeled. This affects two specific lots distributed nationwide. No injuries have been reported.

VistaPharm's Kerr Insta-Char activated charcoal product did not meet the required Over-the-Counter (OTC) Monograph standards set by the FDA. The affected product is a 240 mL bottle containing 50 grams of activated charcoal in a sorbitol base with cherry flavor (Lot #AH001, expiring 8/31/2026).

VistaPharm's Kerr Insta-Char activated charcoal suspension did not meet the standards required for over-the-counter products. The product was distributed nationwide, and affected lots should not be used.

VistaPharm's Kerr Insta-Char activated charcoal product did not meet the required OTC Monograph M023 standards set by the FDA. The affected product is a 240 ml bottle containing 50 grams of activated charcoal with cherry flavor (Lot #AE001, expiring 5/31/2026) distributed nationwide.

VistaPharm's Kerr Insta-Char activated charcoal product failed to meet required Over-the-Counter (OTC) monograph standards. The product may not perform as intended or meet quality requirements for safety and effectiveness.

Glenmark Pharmaceuticals is recalling specific lots of Alyacen 7/7/7 (a birth control pill) because testing found higher-than-allowed impurity levels in the tablets. The affected lots were distributed nationwide. No injuries have been reported.

Sun Pharmaceutical has recalled budesonide inhalation suspension (1mg/2mL single-dose ampules) due to the presence of black or brown specs and particles found in some vials. The affected lot is BAG0074A with an expiration date of January 31, 2027. This is a quality issue that could affect the safety and sterility of the medication.

Ascend Laboratories is recalling Minocycline Hydrochloride Extended-Release Tablets, 115 mg (lot 25141635, expires 4/30/2028) because testing found the tablets did not dissolve properly as required. This affects 360 bottles distributed nationwide. No injuries have been reported.

Gas-X Extra Strength softgels were contaminated with a diluted propylene glycol-based coolant during packaging due to a machine leak. The contamination affected specific lot numbers distributed nationwide. No injuries have been reported.

Golden State Medical Supply is recalling specific lots of niacin extended-release tablets (1,000 mg) because they failed to dissolve properly during stability testing. The tablets did not meet dissolution specifications at the 24-hour mark, which means they may not release the medication as intended in the body.

Zep Inc. is recalling Alcohol Sanitizer Spray (Ethanol 70%, 55-gallon drums) due to microbial contamination. The affected batch (E2612116, expiration April 2029) was distributed nationwide. A total of 5 drums are involved.

Amneal Pharmaceuticals is recalling Primidone 50 mg tablets (NDC 53746-544-01, lot AM251676) due to potential cross-contamination with Acemetacin during manufacturing at the API supplier. The contamination could affect the safety or effectiveness of the medication.

Breckenridge Pharmaceutical is recalling specific lots of Duloxetine Delayed-Release Capsules 60mg due to higher-than-acceptable levels of a chemical impurity called N-nitroso-duloxetine. This impurity was found during manufacturing quality checks. The recall affects about 360,000 bottles distributed nationwide.

Breckenridge Pharmaceutical is recalling one lot of Duloxetine Delayed-Release Capsules 30mg due to the presence of N-nitroso-duloxetine impurity above FDA's recommended interim limit. This is a manufacturing quality issue. No injuries have been reported.

Fresenius Kabi USA is recalling specific batches of epinephrine injection due to failed impurity and degradation specifications. The affected vials may not meet required purity standards. No injuries have been reported.

Sun Pharmaceutical's doxorubicin hydrochloride liposome injection vials were found to contain glass particles. The affected vials are lot HAG2581B, which expire in May 2027. About 675 vials were distributed nationwide.

Beekeeper's Naturals Saline Nasal Spray was manufactured without proper sterilization, allowing microbial contamination. The affected product is Lot #5950 with an expiration date of 02/2028. No injuries have been reported so far.

Beekeeper's Naturals is recalling one lot of its Saline Nasal Spray sold on Amazon because it contains elevated levels of yeast and may be contaminated with Aspergillus, a fungus that can cause serious infections in people with weakened immune systems or lung disease. The company has received four reports of sinus congestion, irritation, or infection potentially linked to this product.

AbbVie is recalling specific lots of PRED MILD (prednisolone acetate) eye drops because they failed stability testing. The affected product may not maintain its intended strength or safety over time. Two lots are involved, with an expiration date of August 2026.

AVEVA nicotine patches (14 mg) distributed by Rugby Laboratories have elevated levels of chemical impurities that exceed safety standards for shelf life. The issue was discovered during stability testing of specific lots. No injuries have been reported.

Wisconsin Pharmacal Company's MG217 Multi-Symptom Treatment Cream (colloidal oatmeal 2%, 6 oz) has been found to contain Staphylococcus aureus bacteria. The contamination was confirmed in lot #1024088 (expiration 11/30/2026). About 690 tubes were distributed nationwide and to the Bahamas.

Safecor Health's Nephronex vitamin B-complex, vitamin C, and folic acid oral liquid supplement was found to contain black particles in the liquid. The affected product is supplied in 5 mL oral syringes. The contamination was identified in three specific lots distributed in Ohio.

IntegraDose Compounding Services LLC has recalled fentanyl citrate sterile injection (2,250 mcg/50 mL) because the drug may contain less active ingredient than labeled. This lot was distributed nationwide to healthcare facilities.

UCB Biosciences is recalling specific lots of Cimzia (certolizumab pegol) 200 mg prefilled syringes because the manufacturer cannot confirm the product remained sterile during production. This is a precautionary recall; no infections or injuries have been reported so far.