FDA drug recalls

Baxter Healthcare Corporation is recalling one lot of Cefazolin in Dextrose injection due to the presence of particulate matter in the solution. The affected product is a frozen premix infusion bag used for intravenous antibiotic treatment. This is a Class I recall, the most serious classification.

Liebel-Flarsheim Company LLC is recalling Optiray Imaging Bulk Package-350 (ioversol injection 74%, 350 mg/mL) due to the presence of particulate matter—including plastic, stainless steel, and glass—found in affected vials. The contamination affects lot #25ZF3670 with an expiration date of May 31, 2027, distributed nationwide in the US and Mexico.

Victory Medical Center Pharmacy's Glutathione injectable solution (200 mg/mL) failed sterility testing and was found to contain elevated bacterial endotoxin levels, which are out of acceptable limits. The affected product was distributed nationwide in specific lots with expiration dates through August 2026.

Buy-Herbal's Kian Pee Wan Capsules contain two prescription drug ingredients—dexamethasone and cyproheptadine—that are not listed on the label and were not approved by the FDA. The product was sold online through eBay. No injuries have been reported.

Heritage Pharmaceuticals' clindamycin palmitate hydrochloride oral solution (75 mg/5 mL) has been recalled due to the presence of particles and white flakes found in reconstituted bottles. The affected lot is 2411550, which expires November 2026. This product was distributed nationwide.

CLEAR EYES Maximum Itchy Eye Relief eye drops may not be sterile due to potential contamination. The affected product is the 0.5 fl oz (15 mL) dropper bottle, Lot 2552A with expiration date 09/30/2027. No injuries have been reported.

The FDA identified Current Good Manufacturing Practice (CGMP) deviations during an inspection of Shoolin Pharma Chem LLP, a supplier of sildenafil citrate USP—an active pharmaceutical ingredient used in prescription compounding. One lot (SDC2505001) distributed nationwide has been recalled due to these manufacturing control issues.

The FDA identified manufacturing practice violations (CGMP deviations) during an inspection of Shoolin Pharma Chem's facility in India. One batch of tadalafil USP powder used for prescription compounding was distributed nationwide in the USA and does not meet required manufacturing standards.

The FDA identified current good manufacturing practice (CGMP) deviations during an inspection of Shoolin Pharma Chem LLP's facility in India. The company manufactures tadalafil USP powder (active pharmaceutical ingredient) intended for prescription compounding use. One batch (TLF2506001, expiring May 31, 2028) totaling 20 kg was distributed nationwide in the USA.

Shoolin Pharma Chem LLP's tadalafil USP powder (lot TLF2506001) was found to have deviations from good manufacturing practices during an FDA inspection. The affected product is a 100-gram bag intended for prescription compounding only.

The FDA identified Current Good Manufacturing Practice (CGMP) deviations during an inspection of Shoolin Pharma Chem LLP's facility in India. Sildenafil citrate bulk powder (batch SDC2505001, expiring April 30, 2030) distributed nationwide for prescription compounding did not meet required manufacturing standards.

Apollo Care's semaglutide 20mg injection vials contain visible particles made of nylon/polyamide and silk-like material. The particles were found during quality testing. The affected vials were distributed nationwide.

Apollo Care's semaglutide 10mg injection vials contain visible particles made of nylon, polyamide, and silk-like material. The contamination was identified in lot AC-017274 (expiration 12/12/2026), affecting 500 vials distributed nationwide. No injuries have been reported.

Apollo Care is recalling one lot of semaglutide 7.5mg injection vials due to the presence of particulate matter (nylon/polyamide and silk-type material) in the medication. The contamination was identified during quality testing. No injuries have been reported to date.

Apollo Care's semaglutide 5mg injection vials contain particulate matter identified as nylon/polyamide and silk/proteinaceous material. This contamination affects one lot (AC-017272, expiring 12/12/2026) of approximately 250 vials distributed nationwide. No injuries have been reported.

Apollo Care is recalling one lot of semaglutide injection due to the presence of visible particles identified as nylon/polyamide and silk material in the vials. The contamination was discovered in lot AC-017271 (expiration 12/12/2026). No injuries have been reported.

Apollo Care's semaglutide 0.9mg injectable medication contains visible particles made of nylon, polyamide, and silk-like material. The contamination was found in one lot (AC-017131, expiring 8/30/2026) affecting approximately 4,748 vials distributed nationwide. No injuries have been reported.

Apollo Care's semaglutide injectable medication (a weight-loss drug) contains small particles of nylon and silk-like material in some vials. The affected lots were distributed nationwide. No injuries have been reported.

Apollo Care's semaglutide injection vials contain small particles of nylon/polyamide and silk material. These particles should not be present in a medication injected under the skin. No injuries have been reported.

Apollo Care semaglutide 6.75 mg injection vials contain particulate matter (nylon/polyamide and silk-type material) that should not be present in the medication. The contamination was identified in multiple lot numbers distributed nationwide. No injuries have been reported.

Apollo Care's semaglutide 2.25mg injection vials contain foreign particles made of nylon, polyamide, and silk-like material. The contamination was identified in specific lots distributed nationwide. No injuries have been reported.

Apollo Care's semaglutide 12.5 mg injectable medication was found to contain small particles of nylon/polyamide and silk-like material. The contamination affects multiple lots distributed nationwide. No injuries have been reported.

One lot of Novartis Diovan (valsartan) 160 mg tablets failed to meet dissolution specifications, which means the tablets may not dissolve properly in the body. This could affect how well the medication works. The affected lot (AV5913C, expiring 6/2027) was distributed nationwide.

Zydus Pharmaceuticals is recalling one lot of Mirabegron Extended-Release 25 mg tablets due to higher-than-acceptable levels of N-Nitroso Mirabegron impurity. This impurity can potentially increase long-term health risks with continued use. No injuries have been reported.

Cyclophosphamide for Injection USP 2 gram vials manufactured by Sunny Pharmtech (for Long Grove Pharmaceuticals) were found to contain stainless steel particulate matter. The affected lot V24010V1 (expiration 3/31/2027) was distributed nationwide. A total of 1,464 vials are involved in this recall.

Cyclophosphamide for Injection, USP (1 gram/vial) manufactured by Sunny Pharmtech Inc. for Long Grove Pharmaceuticals may contain stainless steel particulate matter. The contamination was identified in two specific lots before distribution was completed.

Central Admixture Pharmacy Services Inc. has recalled two patient-specific pediatric Total Parenteral Nutrition (TPN) bags due to incorrect product formulation. The affected bags were compounded with the wrong nutrient mixture. The recall affects only two prescriptions distributed in Georgia with lot numbers 20-1535990-0-1 and 20-1535892-0-1 (expiration July 16, 2026).

Aurobindo Pharma USA is recalling Dicyclomine Hydrochloride Capsules 10mg (Batch DMC125018A, expiration 07/2027) because some bottles contain empty capsules instead of the medication. The issue affects approximately 6,408 bottles distributed nationwide.

Hair was found in Xylocaine (lidocaine HCl Injection, USP) 1% vials distributed nationwide. The affected product is Lot #6133986 with expiration date 02/2029. No injuries have been reported.

Hair was found in vials of Xylocaine (lidocaine HCl Injection, USP) 1% supplied by Fresenius Kabi. The affected product is a multiple-dose vial medication used for local anesthesia. This contamination could pose a risk if the injection is administered without detection.