Drug recalls, 2026-W33

FDA drug recalls, August 10 to 16, 2026

FDA posted 5 drug recalls the week of August 10, 2026: 2 Class I, 2 Class II, and 1 Class III. Sunny Pharmtech Inc. has the most, with 2.

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Recalls posted August 10 to 16, 2026

Class II · Posted August 12, 2026 · Started August 5, 2026 · Ongoing

mirabegron

Product
Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Matoda, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1159-3.
Firm
Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
Reason
CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
Lots
Lot # E408618, Expiry: 11/30/2026, NDC #: 70710-1159-3
Distribution
Nationwide in the USA
RxNorm
mirabegron (RxCUI 1300791, 1300801)
Recall number
D-0745-2026

Class II · Posted August 12, 2026 · Started July 23, 2026 · Ongoing

dicyclomine hydrochloride

Product
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
Firm
Aurobindo Pharma USA Inc, East Windsor, NJ
Reason
shortfill; reports of empty capsules.
Lots
Batch # DMC125018A, Exp Date: 07/2027.
Quantity
6,408 bottles distributed to market
Distribution
US Nationwide.
RxNorm
dicyclomine hydrochloride (RxCUI 991061)
Recall number
D-0733-2026

Class I · Posted August 12, 2026 · Started July 17, 2026 · Ongoing

Cyclophosphamide for Injection

Product
Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8114-1
Firm
Sunny Pharmtech Inc., Taoyuan City, Taiwan
Reason
Presence of Particulate Matter; identified as stainless steel
Lots
Lot # V24010V1, Exp 3/31/2027
Quantity
1,464 vials
Distribution
USA Nationwide
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0744-2026

Class I · Posted August 12, 2026 · Started July 17, 2026 · Ongoing

Cyclophosphamide for Injection

Product
Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx only, Manufactured for: Long Grove Pharmaceuticals, LLC, Rosemont, IL 60018. Manufactured in Taiwan, NDC 81298-8112-1
Firm
Sunny Pharmtech Inc., Taoyuan City, Taiwan
Reason
Presence of Particulate Matter; identified as stainless steel
Lots
Lot # C23019V1, Exp 10/31/2026; C24015V1, Exp 4/30/2027
Quantity
4,077 vials
Distribution
USA Nationwide
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0743-2026

Class III · Posted August 12, 2026 · Started July 16, 2026 · Ongoing

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag

Product
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient specific), Compound Volume 416.8 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Inc., Atlanta, 1750 Corp Dr. Ste 725, Norcross, GA 30093 (844) 903-6418
Firm
Central Admixture Pharmacy Services Inc, Norcross, GA
Reason
Incorrect Product Formulation
Lots
Lot #: 20-1535990-0-1 & 20-1535892-0-1, Exp. Date 16 July 2026
Quantity
(2) patient-specific TPN prescriptions
Distribution
GA only
RxNorm
Not matched to RxNorm in the FDA record
Recall number
D-0740-2026

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.

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

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FDA drug recalls, August 10 to 16, 2026 (2026-W33): 5 recalls, 2 Class I · Rivvi