Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
51 recalls
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Class II Ongoing
Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90), b). 500-count (NDC 67877-512-05), c). 1000-count(NDC 67877-512-10),Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Lots / codes
- Lot #: 25140150, Exp. Dec. 2026 Lot #: 25140173, Exp. Dec. 2026 Lot #: 25140172, Exp. Dec. 2026 Lot #: 24144720, Exp. Nov. 2026 Lot #: 24144798, Exp. Nov. 2026 Lot #: 24144692, Exp. Oct. 2026 Lot #: 24143755, Exp. Aug. 2026 Lot #: 24143913, Exp. Aug. 2026 Lot #: 24143754, Exp. Aug. 2026 Lot #: 24143047, Exp. June 2026 Lot #: 24142936, Exp. July 2026
- Distribution
- U.S. Nationwide
- Quantity
- —
- Recall started
- September 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0019-2026
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Class II Ongoing
Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Asc…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets USP, 40 mg, Rx Only, a). 90-count (NDC 67877-513-90), b). 500-count (NDC 67877-513-05), c). 1000-count (NDC 67877-513-10), Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Lots / codes
- Lot#: 25140933, Exp. Feb. 2027 Lot#: 25140477, Exp. Dec. 2026 Lot#: 24144254, Exp. Oct. 2026 Lot#: 24144163, Exp. Sep. 2026 Lot#: 24143995, Exp. Sep. 2026
- Distribution
- U.S. Nationwide
- Quantity
- —
- Recall started
- September 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0018-2026
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Class II Ongoing
Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, D…
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets USP, 10 mg, Rx Only a) 90-count bottle (NDC 67877-511-90), b). 500-count bottle (NDC 67877-511-05), c). 1000-count bottle (NDC 67877-511-10) Manufactured by: Alkem Laboratories, Ltd. India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054.
- Lots / codes
- Lot#: 25141249, Exp. Feb. 2027 Lot#: 24144938, Exp. Nov. 2026 Lot#: 24144868, Exp. Nov. 2026 Lot#: 24144867, Exp. Nov. 2026 Lot#: 24144458, Exp. Sep. 2026 Lot#: 24143994, Exp. Sep. 2026 Lot#: 24142987, Exp. July 2026 Lot#: 24143316, Exp. July 2026
- Distribution
- U.S. Nationwide
- Quantity
- 141,984 bottles
- Recall started
- September 19, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0017-2026
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Class II Ongoing
Calcium Chloride for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- All lots within expiry.
- Distribution
- US Nationwide.
- Quantity
- 184
- Recall started
- July 30, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0049-2026
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Class II Ongoing
Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377…
Reason: Failed dissolution specifications: lower than specifications
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets USP 40 mg, 1000-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA, Manufactured by: Recipharm Pharmaservices PVT, Ltd Bengaluru, INDIA -562-123, NDC 70377-079-13
- Lots / codes
- Lot#: AVC24035, Exp 03/31/26
- Distribution
- U.S.A. nationwide
- Quantity
- 2184 bottles
- Recall started
- March 17, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0306-2025
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Class II Ongoing
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
Reason: cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Lots, distribution and details
- Lots / codes
- Lot# 24A0073, exp. date 06/28/2026
- Distribution
- USA nationwide.
- Quantity
- 791 boxes
- Recall started
- November 11, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0059-2025
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Class II Terminated
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, I…
Reason: Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
- Lots / codes
- Lot #: U24T0408A, Exp: 03/31/2026
- Distribution
- Nationwide within the U.S
- Quantity
- 2328 bottles
- Recall started
- September 24, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0001-2025
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Class II Ongoing
DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitone…
Reason: This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Lots, distribution and details
- Product
- DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
- Lots / codes
- 24AU03024, exp. date 07/31/2025
- Distribution
- Nationwide
- Quantity
- 183 cases
- Recall started
- June 18, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0608-2024
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Class II Ongoing
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-0…
Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Lots, distribution and details
- Product
- Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
- Lots / codes
- Lot R24B25FA; Exp. 2/28/2026
- Distribution
- US Nationwide, Canada
- Quantity
- 6,874 bags
- Recall started
- June 17, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0587-2024
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Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Lots, distribution and details
- Lots / codes
- Lot#: KH5L, Exp. Date 09/30/2027
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- December 2, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0079-2024
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Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Lots, distribution and details
- Lots / codes
- Lot #: J96X,J96W, Exp. Date 09/30/2027
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- December 2, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0078-2024
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Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Lots, distribution and details
- Lots / codes
- Lot#: HR6A, Exp. Date 09/30/2027
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- December 2, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0077-2024
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Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Lots, distribution and details
- Lots / codes
- Lot #: HR5W, Exp. Date 09/30/2027
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- December 2, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0076-2024
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Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Lots, distribution and details
- Product
- TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2
- Lots / codes
- Lot #: HV6B, Exp. Date 9/30/2027
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- December 2, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0075-2024
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Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Lots, distribution and details
- Lots / codes
- Lot #: HA7G, Exp. Date 8/31/2027
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- December 2, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0074-2024
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Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Lots, distribution and details
- Lots / codes
- Lot#: HB2G, Exp. Date 8/31/2027
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- December 2, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0073-2024
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Class II Ongoing
Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52
Reason: CGMP Deviations
Lots, distribution and details
- Product
- Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52
- Lots / codes
- Lot # F117192201, Exp. Date 4/30/2023
- Distribution
- Nationwide with the United States
- Quantity
- 99 bottles
- Recall started
- March 16, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0548-2023
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Class II Ongoing
Atorvastatin Calcium Tablets, USP, 20 mg, packaged in: a) 90-count bottle (NDC 68788-7631-9); b) 30-count bottle (NDC 68788-7631-3), Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Lots, distribution and details
- Lots / codes
- a) Lot: B1522B, Exp 4/30/2023; lot:C0222H, C0322B, Exp 5/31/2023; lot: E1022H, F13220, H2222P, Exp 6/30/2023; Lot: I1422V, K01220, Exp 12/31/2023; Lot: L2722H, Exp 3/31/2024; b) Lot:C0322B, Exp 5/31/2023; lot:H1122G, 12322Q, Exp 6/30/2023; lot: J1222U, Exp 12/31/2023.
- Distribution
- USA Nationwide
- Quantity
- a) 375 Bottles b) 323 Bottles
- Recall started
- March 23, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0512-2023
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Class II Ongoing
Atorvastatin Calcium Tablets, USP, 10 mg, 90-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7630-9
Reason: cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Lots, distribution and details
- Lots / codes
- Lot #: A0523D, Exp 5/31/2024, F14220, Exp 7/31/2023, J0622Q; Exp 1/31/2024.
- Distribution
- USA Nationwide
- Quantity
- 158 Bottles
- Recall started
- March 23, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0511-2023
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Class II Ongoing
Calcium Chloride Preservative Free, 100mg/mL, a) 5 mL-vial, b) 30 ml-vial, Room Temperature, Tailor Made Compounding
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Lots / codes
- Batch #: a) 12072101A2, Exp 3/7/2022; 01042216A1, Exp 4/4/2022; 02142220A1, Exp 5/15/2022; b)12032129A2, Exp 3/3/2022; 02142220A1, Exp 5/15/2022; 03032213A1, Exp 6/1/2022; 03102214B, Exp 6/8/2022.
- Distribution
- Nationwide USA and Puerto Rico
- Quantity
- 138 vials
- Recall started
- March 7, 2022 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1198-2022
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Class II Ongoing
Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosp…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU + Vitamin A Acetate 100 IU/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 07182016A (12/31/2016)
- Distribution
- Nationwide
- Quantity
- 21 vials
- Recall started
- November 17, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0275-2017
-
Class II Ongoing
Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosp…
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 06202016DD (06/21/2016), 09132016B (02/28/2017)
- Distribution
- Nationwide
- Quantity
- 66 vials
- Recall started
- November 17, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0274-2017
-
Class II Ongoing
Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy
Reason: Lack of Assurance of Sterility
Lots, distribution and details
- Product
- Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy
- Lots / codes
- Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 08172016A (02/13/2017).
- Distribution
- Nationwide
- Quantity
- 12 vials
- Recall started
- November 17, 2016 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0254-2017
-
Class II Ongoing
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 — NDC 0409-3796-01 —- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
Reason: Crystallization; identified as calcium salt of Ketorolac
Lots, distribution and details
- Lots / codes
- 31075DK, 31076DK, EXP01JUL2015; 32345DK, 32368DK, EXP 01AUG2015; 33152DK, EXP 01SEP2015; 34538DK, EXP 01OCT2015; 37227DK, EXP 01JAN2016, 41525DK, 42255DK, EXP 01MAY2016; 46042DK, 46045DK, 46048DK, 46304DK, 46305DK, 46432DK, 46433DK, EXP 01OCT2016 AND NOVAPLUS LOT 31074DK, EXP 01JUL2015
- Distribution
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- Quantity
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
- Recall started
- June 30, 2015 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1242-2015
-
Class II Ongoing
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 — NDC 0409-3795-01 — Also labeled under NOVAPLUS label NDC 0409-3795-49
Reason: Crystallization; identified as calcium salt of Ketorolac
Lots, distribution and details
- Lots / codes
- 31077DK, 31078DK, 31338DK, 31339DK, 31340DK, EXP 01JUL2015; 32068DK, 32069DK, EXP 01AUG2915; 33270DK, EXP 01SEP2015; 34084DK, 34085DK, 34161DK, 34162DK, 34298DK, 34299DK, 34300DK, EXP 01OCT2015; 35011DK, 35081DK, 35082DK, 35116DK, EXP 01NOV2015; 38139DK, 38140DK, 36144DK, EXP 01FEB2016; 39256DK, 39257DK, EXP 01MAR2016; 42210DK, 42227DK, EXP01JUN2016; 43017DK, 43116DK, 43117DK, 43292DK, 43293DK, EXP 01JUL2016; 45034DK, 45035DK, 45118DK, 45120DK, EXP 01SEP2016; 46310DK, 46311DK, EXP 01OCT2016 AND NOVAPLUS LOTS 32106DK, 32220DK, 32221DK, EXP 01AUG2015; 33235DK, 33236DK, EXP 01SEP2015; 34163DK, 34164DK, EXP 01OCT2015; 39263DK, 39264DK, EXP 01MAR2016
- Distribution
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- Quantity
- 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
- Recall started
- June 30, 2015 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-1241-2015
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.