FDA enforcement

FDA drug recalls, May 11 to 17, 2026

FDA posted 14 drug recalls the week of May 11, 2026: 1 Class I, 12 Class II, and 1 Class III. Ajanta Pharma Ltd. has the most, with 3.

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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.

Recalls posted May 11 to 17, 2026

Class II · Posted May 13, 2026 · Started April 29, 2026 · Ongoing

duloxetine

Product: Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-097-06.
Firm: Ajanta Pharma Ltd., Aurangabad, India
Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Lots: Lot#: PA10734, Exp. Jun 2026.
Quantity: 117,168 packs
Distribution: Nationwide within U.S
RxNorm: duloxetine (RxCUI 596926, 596930, 596934, 616402)
Recall number: D-0516-2026

Class II · Posted May 13, 2026 · Started April 29, 2026 · Ongoing

duloxetine

Product: Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-099-03
Firm: Ajanta Pharma Ltd., Aurangabad, India
Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Lots: Lot#: PA07434, Exp. May 2026.
Quantity: 77,376 packs.
Distribution: Nationwide within U.S
RxNorm: duloxetine (RxCUI 596926, 596930, 596934, 616402)
Recall number: D-0515-2026

Class II · Posted May 13, 2026 · Started April 29, 2026 · Ongoing

duloxetine

Product: Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-098-09, b) 30 capsules, NDC 27241-098-03, c) 1000 Capsules, NDC 27241-098-10, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India
Firm: Ajanta Pharma Ltd., Aurangabad, India
Reason: CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Lots: Lot#: a) PA10774, Exp. May 2026; b) PA10794, PA12174, Exp. Jun 2026; c) PA10804, Exp. Jun-26.
Quantity: 312,894 packs
Distribution: Nationwide within U.S
RxNorm: duloxetine (RxCUI 596926, 596930, 596934, 616402)
Recall number: D-0514-2026

Class I · Posted May 13, 2026 · Started April 28, 2026 · Ongoing

sodium chloride, sodium lactate, potassium chloride, and calcium chloride

Product: Lactated Ringer's Injection USP, 1000 mL container, Rx only, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-07.
Firm: B BRAUN MEDICAL INC, Allentown, PA
Reason: Presence of Particulate Matter.
Lots: Lot #:J4P756, J4S843, Exp 5/31/2027
Quantity: 95,412 containers
Distribution: U.S.A. Nationwide
RxNorm: sodium chloride, sodium lactate, potassium chloride, and calcium chloride (RxCUI 847630)
Recall number: D-0540-2026

Class II · Posted May 13, 2026 · Started April 24, 2026 · Ongoing

octreotide acetate

Product: Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL vial of 30 mg strength, a pre-filled syringe containing 2 mL of diluent, one vial adapter, and one sterile 1¿ 19-gauge safety injection needle, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 69300 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054. NDC Kit Carton: 0480-9262-08; Vial Label: 0480-9260-01; Tray Label: 0480-9262-08; Diluent Label: 0480-9263-21.
Firm: Teva Pharmaceuticals USA, Inc, Parsippany, NJ
Reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Lots: Lot: 45011002, Exp. 03/31/2027
Quantity: 2,200 kits
Distribution: Nationwide in the USA
RxNorm: octreotide acetate (RxCUI 898589, 898601, 898605)
Recall number: D-0519-2026

Class II · Posted May 13, 2026 · Started April 23, 2026 · Ongoing

enalapril maleate

Product: Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only, Manufactured by: Unique Pharmaceutical Laboratories (A Div. of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 64980-688-10.
Firm: JB Chemicals and Pharmaceuticals Ltd, Mumbai, India
Reason: Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test
Lots: Lot #: GEH25023, Expires: 6/30/2027
Quantity: 675 bottles
Distribution: Nationwide in the USA
RxNorm: enalapril maleate (RxCUI 858804, 858810, 858813, 858817)
Recall number: D-0520-2026

Class II · Posted May 13, 2026 · Started April 22, 2026 · Ongoing

povidone iodine and isopropyl alcohol

Product: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41
Firm: CareFusion 213, LLC, El Paso, TX
Reason: Lack of assurance of Sterility: potential product contamination
Lots: Lots# 4263873, Exp. Date 08-31-2026, 4320590, Exp. Date 09-30-2026, 4320591, Exp. Date 10-31-2026.
Distribution: Nationwide in the USA
RxNorm: povidone iodine and isopropyl alcohol (RxCUI 1052725)
Recall number: D-0518-2026

Class II · Posted May 13, 2026 · Started April 22, 2026 · Ongoing

povidone iodine and isopropyl alcohol

Product: BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
Firm: CareFusion 213, LLC, El Paso, TX
Reason: Lack of assurance of Sterility: potential product contamination
Lots: Lot# 4258309, 4260329, 4256875, Exp. Date, 08-31-2026; 4296453, 4317319, 4290654, Exp. Date 09-30-2026; 4322449, 4323861, 4318679, Exp Date 10-31- Exp.
Distribution: Nationwide in the USA
RxNorm: povidone iodine and isopropyl alcohol (RxCUI 1052725)
Recall number: D-0517-2026

Class II · Posted May 13, 2026 · Started April 21, 2026 · Ongoing

duloxetine hydrochloride

Product: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Firm: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Lots: Lot: 241069C, Exp 05/31/2027
Quantity: 165,761 90-count bottles
Distribution: Nationwide in the USA
RxNorm: duloxetine hydrochloride (RxCUI 596926, 596930, 596934, 616402)
Recall number: D-0522-2026

Class II · Posted May 13, 2026 · Started April 20, 2026 · Ongoing

naproxen

Product: NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, Made in Canada NDC 42192-619-16
Firm: Acella Pharmaceuticals, LLC, Alpharetta, GA
Reason: Chemical contamination; presence of lead and lithium above specification
Lots: Lot: 23F02, Expires: 05/2026; 25A37, Expires: 01/2028.
Quantity: 6,336 bottles
Distribution: Nationwide
RxNorm: naproxen (RxCUI 311913)
Recall number: D-0523-2026

Class III · Posted May 13, 2026 · Started April 13, 2026 · Ongoing

buspirone hydrochloride

Product: busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, NDC 29300-244-05.
Firm: Unichem Pharmaceuticals USA Inc., East Brunswick, NJ
Reason: Subpotent drug
Lots: Lot: ZBUL25001, Exp 12/31/2027
Quantity: 10,875 Bottles
Distribution: USA Nationwide
RxNorm: buspirone hydrochloride (RxCUI 866018, 866083, 866090, 866094)
Recall number: D-0511-2026

Class II · Posted May 13, 2026 · Started April 6, 2026 · Ongoing

DELFLEX

Product: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 2.5% DEX. LM/LC, 2L 5PK, Part Number 054-20222, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA
Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Lots: Lots 25CU02002, 25CU02011, 25CU02012, 25CU02013
Quantity: 43,225 bags
Distribution: Nationwide in the USA
RxNorm: Not matched to RxNorm in the FDA record
Recall number: D-0513-2026

Class II · Posted May 13, 2026 · Started April 6, 2026 · Ongoing

DELFLEX

Product: DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set for Intraperitoneal Dialysis Only, 1.5% DEX. LM/LC, 2L 5PK, Part Number 054-20221, Fresenius Medical Care North America, 920 Winter Street, Waltham, MA 02451.
Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA
Reason: Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Lots: Lot #: 25CU02007, 25CU02008, 25CU02009
Quantity: 37,215 bags
Distribution: Nationwide in the USA
RxNorm: Not matched to RxNorm in the FDA record
Recall number: D-0512-2026

Class II · Posted May 13, 2026 · Started December 27, 2025 · Ongoing

TPN bag (patient specific)

Product: TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag, Rx only, Single Dose Injection, Refrigerated Injection, Central Admixture Pharmacy Services, Los Angeles, 13128 Imperial Hwy, Santa Fe Spr., CA 90670
Firm: Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles, Santa Fe Springs, CA
Reason: Incorrect Product Formulation: product did not contain insulin as listed in the label.
Lots: Lot #: 11-4909703-0-1, Exp 12/28/2025
Quantity: 1 bag
Distribution: CA
RxNorm: Not matched to RxNorm in the FDA record
Recall number: D-0524-2026

Source: openFDA drug enforcement reports, as of October 21, 2026. Publisher page

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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 21, 2026. Publisher page

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Recalls posted May 11 to 17, 2026

duloxetine

duloxetine

duloxetine

sodium chloride, sodium lactate, potassium chloride, and calcium chloride

octreotide acetate

enalapril maleate

povidone iodine and isopropyl alcohol

povidone iodine and isopropyl alcohol

duloxetine hydrochloride

naproxen

buspirone hydrochloride

DELFLEX

DELFLEX

TPN bag (patient specific)

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