Drug recalls, 2026-W13

FDA drug recalls, March 23 to 29, 2026

FDA posted 5 drug recalls the week of March 23, 2026: 1 Class I, 3 Class II, and 1 Class III.

License: openFDA publishes this file under CC0 1.0.

FDA sorts recalls by risk. Class I: using the product could cause serious health problems or death. Class II: it could cause temporary or reversible health problems. Class III: it is unlikely to cause health problems.

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Recalls posted March 23 to 29, 2026

Class II · Posted March 25, 2026 · Started March 5, 2026 · Ongoing

brimonidine tartrate and timolol maleate

Product: Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
Firm: Apotex Corp., Weston, FL
Reason: Lack of Assurance of Sterility
Lots: Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
Quantity: 107,136 vials
Distribution: U.S. Nationwide
RxNorm: brimonidine tartrate and timolol maleate (RxCUI 861635)
Recall number: D-0407-2026

Class I · Posted March 25, 2026 · Started March 2, 2026 · Ongoing

Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply

Product: Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Firm: Cardinal Health 200, LLC, Waukegan, IL
Reason: Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
Lots: Lot #: 25H065362; 25J013962; 25J034762; 25J064562; 25K004962; 25K041262; 25K065062; 25L015362; 25H065462; 25J014062; 25J035762; 25J064762; 25K005062; 25K041362; 25K065162; 25L015462; 25H066062; 25J014862; 25J035862; 25J064862; 25K006162; 25K041462; 25K065262; 25L015662; 25H066162; 25J014962; 25J035962; 25J064962; 25K006262; 25K041562; 25K065362; 25L016362; 25H066262; 25J033962; 25J050362; 25J065762; 25K006362; 25K041662; 25K064562; 25L015962; 25H066362; 25J034862; 25J050462; 25J066262; 25K005162; 25K040462; 25K064662; 25L016062; 25H066462; 25J034062; 25J050562; 25J066362; 25K006462…
Quantity: 174,380,282 boxes
Distribution: Nationwide within the United States, Puerto Rico and Japan.
RxNorm: Not matched to RxNorm in the FDA record
Recall number: D-0528-2026

Class II · Posted March 25, 2026 · Started March 2, 2026 · Ongoing

ibuprofen

Product: Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Firm: STRIDES PHARMA INC, Bridgewater, NJ
Reason: Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
Lots: Lot: 7261973A, 7261974A, Exp 01/31/2027
Quantity: 89592 bottles
Distribution: U.S.A. Nationwide
RxNorm: ibuprofen (RxCUI 197803)
Recall number: D-0390-2026

Class II · Posted March 25, 2026 · Started February 4, 2026 · Ongoing

dexamethasone sodium phosphate

Product: Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
Firm: SOMERSET THERAPEUTICS LLC, Somerset, NJ
Reason: Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
Lots: Lot #: A240421, Exp 07/31/2026
Quantity: 62190 vials
Distribution: Nationwide in the USA
RxNorm: dexamethasone sodium phosphate (RxCUI 309696)
Recall number: D-0398-2026

Class III · Posted March 25, 2026 · Started February 3, 2026 · Ongoing

pitavastatin calcium

Product: Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
Firm: Annora Pharma Private Limited, Hyderabad, India
Reason: Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Lots: Lot #: A252487, Exp 05/31/2027
Quantity: 770 bottles
Distribution: TN
RxNorm: pitavastatin calcium (RxCUI 861648, 861652)
Recall number: D-0391-2026

Source: openFDA drug enforcement reports, as of October 14, 2026. Publisher page

About this data

Each row is one FDA drug enforcement report: one product from one firm. A week here is Monday to Sunday, keyed on the date FDA listed the recall in its weekly Enforcement Report. The date the firm started the recall is shown on each row and is often weeks earlier.

Class I means use of the product could cause serious health problems or death. Class II means it could cause temporary or reversible health problems. Class III means it is unlikely to cause health problems. RxNorm names and RxCUIs come from openFDA's match of the product to its drug label. Compounded products often have no match.

This page lists public records. It is not medical advice. Check the FDA record before acting on a recall.