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Common antibiotics

FDA recalls

53 rows

DateCompany and reasonClass
Sep 28, 2025Acella Pharmaceuticals, LLC
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.		Class II · Ongoing
Sep 1, 2025The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.		Class II · Ongoing
Aug 19, 2025Northwind Pharmaceuticals LLC
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.		Class II · Ongoing
Aug 17, 2025Amneal Pharmaceuticals, LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.		Class II · Ongoing
Jun 1, 2025Amneal Pharmaceuticals, LLC
Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.		Class I · Ongoing
Mar 12, 2025Glenmark Pharmaceuticals Inc., USA
CGMP Deviations		Class II · Ongoing
Jul 8, 2024Sun Pharmaceutical Industries Inc
Failed Dissolution Specifications		Class II · Terminated
May 9, 2024Bryant Ranch Prepack, Inc.
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'		Class III · Ongoing
May 9, 2024Bryant Ranch Prepack, Inc.
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g		Class III · Ongoing
May 9, 2024Bryant Ranch Prepack, Inc.
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'		Class III · Ongoing
May 9, 2024Bryant Ranch Prepack, Inc.
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'		Class III · Ongoing
May 7, 2024Lupin Pharmaceuticals Inc.
Defective container: lack of seal integrity.		Class II · Terminated
Apr 23, 2024Lupin Pharmaceuticals Inc.
Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.		Class II · Terminated
Apr 12, 2022McKesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse		Class II · Terminated
Apr 12, 2022McKesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse		Class II · Terminated
Apr 12, 2022McKesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse		Class II · Terminated
Apr 12, 2022McKesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse		Class II · Terminated
Apr 12, 2022McKesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse		Class II · Terminated
Apr 12, 2022McKesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse		Class II · Terminated
Jan 25, 2022Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.		Class II · Terminated
Jan 25, 2022Cardinal Healthcare
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.		Class II · Terminated
Jul 6, 2021Aurobindo Pharma USA Inc.
Presence of Foreign Substance- Potential of metal contamination.		Class II · Terminated
Apr 11, 2021Preferred Pharmaceuticals, Inc.
Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin		Class II · Ongoing
Mar 14, 2021Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.		Class II · Terminated
Aug 9, 2020Aurobindo Pharma USA Inc.
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).		Class II · Terminated
Jul 1, 2020Lupin Pharmaceuticals Inc.
Superpotent Drug: Out-of-specification (OOS) result observed in an assay test of retention samples.		Class II · Terminated
May 21, 2020The Harvard Drug Group
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.		Class II · Terminated
May 18, 2020American Health PAckaging
Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month time point (end of shelf life).		Class II · Terminated
May 14, 2020Pd-Rx Pharmaceuticals, Inc.
Failed dissolution specifications		Class II · Terminated
May 12, 2020West-Ward Columbus Inc
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.		Class II · Terminated
Mar 12, 2020Sun Pharmaceutical Industries, Inc.
CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.		Class II · Terminated
Oct 31, 2019Lupin Pharmaceuticals Inc.
Presence of Foreign substance: identified as a dead ant.		Class III · Terminated
May 22, 2019Lupin Pharmaceuticals Inc.
Complaint received of metal piece identified in the product bottle prior to the reconstitution.		Class II · Terminated
Jan 8, 2019Lupin Pharmaceuticals Inc.
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.		Class II · Terminated
Jan 1, 2019Lupin Pharmaceuticals Inc.
CGMP Deviations: Product complaints received indicating reconstituted suspension was observed to be thick.		Class II · Terminated
Dec 20, 2018Lupin Somerset
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.		Class II · Terminated
Sep 24, 2018Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.		Class III · Terminated
Aug 6, 2018Pd-Rx Pharmaceuticals, Inc.
Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.		Class II · Terminated
Jul 31, 2018American Health PAckaging
Failed Dissolution Specifications: Out of specification result for the dissolution test.		Class II · Terminated
Jul 31, 2018Baxter Healthcare Corporation
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.		Class III · Terminated
Jul 29, 2018Major Pharmaceuticals
Failed Dissolution Specifications		Class II · Terminated
Jul 23, 2018West-Ward Columbus Inc
Failed Dissolution Specifications:		Class II · Terminated
Jun 27, 2018Lupin Somerset
Subpotent Drug and Failed Content Uniformity.		Class II · Terminated
Apr 18, 2018Sun Pharmaceutical Industries, Inc.
Presence of Foreign Substance:Sun Pharma is recalling one lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two tablets.		Class II · Terminated
Mar 26, 2018Lupin Pharmaceuticals Inc.
Superpotent Drug		Class II · Terminated
Mar 9, 2017Claris Lifesciences Inc
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.		Class II · Terminated
Nov 3, 2016West-Ward Pharmaceuticals Corp.
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.		Class III · Terminated
Jun 23, 2016Teva North America
Superpotent drug: Out of specification test result for assay during stability testing.		Class II · Terminated
Jun 17, 2013Teva Pharmaceuticals USA, Inc.
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.		Class III · Terminated
Apr 25, 2013Teva Pharmaceuticals USA, Inc.
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.		Class III · Terminated
Apr 17, 2013Sandoz Incorporated
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.		Class II · Terminated
Feb 25, 2013Teva Pharmaceuticals USA, Inc.
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.		Class II · Terminated
Sep 26, 2011Shamrock Medical Solutions Group LLC
Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).