Aurolife Pharma, LLC
NDC labeler code: 13107
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 7 products
- Clorazepate dipotassium6 products
- Hydrocodone bitartrate and acetaminophenNorco · 6 products
- Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 5 products
- Oxycodone and acetaminophenEndocet, Prolate, Percocet · 4 products
- Trazodone hydrochlorideRaldesy Tm · 4 products
- MirtazapineRemeronsoltab, Remeron · 4 products
- ParoxetinePaxil, Paxil CR, Brisdelle · 4 products
- Acetaminophen and codeine phosphate3 products
- Phentermine hydrochlorideLomaira · 3 products
- LorazepamAtivan, Loreev XR · 3 products
- Hydromorphone hydrochlorideDilaudid · 3 products
- MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 3 products
- DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 2 products
- Oxymorphone hydrochloride2 products
- AmphetamineAdzenys Xr-Odt, Dyanavel XR, Evekeo · 2 products
- Methadone hydrochlorideMethadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Sugar-Free · 2 products
- Beclomethasone dipropionate HFAQvar Redihaler, Qnasl · 2 products
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 2 products
- Butalbital, acetaminophen and caffeineFioricet · 1 product
- Hydrocodone bitartrate and ibuprofen1 product
- DiclofenacZipsor, Lofena, Cambia · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| September 14, 2026 | ANDA214418 | Beclomethasone dipropionate HFA BECLOMETHASONE DIPROPIONATE | Aurolife Pharma LLC |
| February 3, 2023 | ANDA213040 | Diclofenac DICLOFENAC SODIUM | Aurolife Pharma LLC |
| February 5, 2020 | ANDA204852 | Trazodone hydrochloride TRAZODONE HYDROCHLORIDE | Aurobindo Pharma |
| January 27, 2020 | ANDA212429 | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE | Aurolife Pharma LLC |
| April 17, 2019 | ANDA211639 | Amphetamine AMPHETAMINE SULFATE | Aurolife Pharma LLC |
| October 25, 2018 | ANDA209276 | Methylphenidate METHYLPHENIDATE HYDROCHLORIDE | Aurolife Pharma LLC |
| September 26, 2018 | ANDA204733 | Butalbital, acetaminophen and caffeine BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | Aurolife Pharma LLC |
| September 13, 2018 | ANDA207709 | Hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Aurolife Pharma LLC |
| December 22, 2017 | ANDA203572 | Lorazepam LORAZEPAM | Aurobindo Pharma |
| November 9, 2016 | ANDA204318 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Aurolife Pharma LLC |
| June 2, 2016 | ANDA204575 | Hydrocodone bitartrate and ibuprofen HYDROCODONE BITARTRATE AND IBUPROFEN | Aurolife Pharma LLC |
| May 13, 2016 | ANDA205814 | Hydromorphone hydrochloride HYDROMORPHONE HYDROCHLORIDE | Aurolife Pharma LLC |
| April 26, 2016 | ANDA204459 | Oxymorphone hydrochloride OXYMORPHONE HYDROCHLORIDE | Aurolife Pharma LLC |
| August 31, 2015 | ANDA203502 | Methadone hydrochloride METHADONE HYDROCHLORIDE | Aurolife Pharma LLC |
| August 6, 2014 | ANDA203068 | Phentermine hydrochloride PHENTERMINE HYDROCHLORIDE | Aurobindo Pharma Ltd |
| November 27, 2013 | ANDA202424 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Aurolife Pharma LLC |
| July 31, 2013 | ANDA202893 | Dextroamphetamine DEXTROAMPHETAMINE SULFATE | Aurolife Pharma LLC |
| July 15, 2013 | ANDA201972 | Oxycodone and acetaminophen OXYCODONE AND ACETAMINOPHEN | Aurolife Pharma LLC |
| April 15, 2013 | ANDA202675 | Glycopyrrolate GLYCOPYRROLATE | Aurobindo Pharma |
| April 15, 2013 | ANDA202800 | Acetaminophen and codeine phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE | Aurolife Pharma LLC |
| November 19, 2012 | ANDA202160 | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE | Aurolife Pharma LLC |
| April 11, 2012 | ANDA201013 | Hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Aurolife Pharma LLC |
| July 25, 2007 | ANDA078406 | Paroxetine PAROXETINE HYDROCHLORIDE | Aurobindo Pharma |
| October 22, 2004 | ANDA076921 | Mirtazapine MIRTAZAPINE | Aurobindo |
| July 17, 1987 | ANDA071858 | Clorazepate dipotassium CLORAZEPATE DIPOTASSIUM | Aurobindo Pharma |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
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April 24, 2024 · Class II · Ongoing · D-0492-2024 · Clorazepate dipotassium
Discoloration: Dotted and yellow spots on tablets
Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E
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April 24, 2024 · Class II · Ongoing · D-0491-2024 · Clorazepate dipotassium
Discoloration: Dotted and yellow spots on tablets
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, E
2023
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May 18, 2023 · Class III · Terminated · D-0877-2023 · Glycopyrrolate
Failed Impurities/Degradation Specifications
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
2022
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December 16, 2022 · Class II · Ongoing · D-0087-2023 · Glycopyrrolate
Failed Impurities/Degradation Specifications
Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01
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March 17, 2022 · Class II · Terminated · D-0736-2022 · Glycopyrrolate
Presence of Foreign Substance: Complaint for pieces of glass discovered in a sealed bottle which came from equipment within the packaging room.
Glycopyrrolate Tablets, USP, 1 mg, 100-count bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, NDC 13107-014-01.
2020
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March 18, 2020 · Class II · Terminated · D-1236-2020 · Phentermine hydrochloride
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
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March 18, 2020 · Class II · Terminated · D-1235-2020 · Mirtazapine
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
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March 18, 2020 · Class II · Terminated · D-1231-2020 · Acetaminophen and codeine phosphate
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
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March 18, 2020 · Class II · Terminated · D-1230-2020 · Acetaminophen and codeine phosphate
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
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March 18, 2020 · Class II · Terminated · D-1237-2020 · Oxycodone and acetaminophen
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
Show the 5 older recalls
2020
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March 18, 2020 · Class II · Terminated · D-1229-2020 · Acetaminophen and codeine phosphate
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
2019
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November 20, 2019 · Class I · Terminated · D-0636-2020 · Mirtazapine
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
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November 20, 2019 · Class I · Terminated · D-0637-2020 · Mirtazapine
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
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September 19, 2019 · Class II · Terminated · D-0143-2020 · Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobin
2018
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April 24, 2018 · Class II · Terminated · D-0806-2018 · Acetaminophen and codeine phosphate
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreSc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
- All drug companiesA to Z
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026