Aurobindo Pharma USA Inc recalls
Every recall we track for Aurobindo Pharma USA Inc — 59 in all, from 2013–2026 — plus the complaints and injury reports the public filed about them. 6 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Aurobindo Pharma USA Inc fell by more than half in 2025 (1, down from 7 in 2024). 11% rated “stop using now”.
All FDA recall records for Aurobindo Pharma USA Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 4 | 1 | 8 | 3 | 16 |
| 2019 | 0 | 0 | 3 | 0 | 3 |
| 2020 | 0 | 0 | 9 | 5 | 14 |
| 2021 | 1 | 0 | 1 | 3 | 5 |
| 2022 | 1 | 2 | 0 | 0 | 3 |
| 2023 | 0 | 0 | 2 | 2 | 4 |
| 2024 | 0 | 0 | 3 | 4 | 7 |
| 2025 | 0 | 0 | 1 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
Aurobindo Pharma USA Inc recalls before 2017
Recalls on record by year.
Most common reasons for Aurobindo Pharma USA Inc recalls
What to do if you have a recalled Aurobindo Pharma USA Inc product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Aurobindo Pharma USA Inc recalls
33 shown- Lower riskDrug
Aurobindo Pharma USA Inc recalls Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Aurobindo Pharma USA recalls 10mg Dicyclomine Hydrochloride Capsules (1,000 bottles) after reports of empty capsules. This prescription drug was distributed by Aurobindo Pharma USA, Inc. in New Jersey.
Aurobindo PharmaJul 23, 2026 - Lower riskDrug
Aurobindo Pharma USA Inc recalls Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N.,
Aurobindo Pharma recalls 325mg acetaminophen tablets with brown surface discoloration due to manufacturing issues. Consumers should check NDC 72288-405-10 and lot number AEF124004A for affected products.
Aurobindo PharmaMay 22, 2025 - UnratedDrug
Aurobindo Pharma USA Inc recalls Nebivolol Tablets, 2.5. mg, 30-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Aurobindo Pharma recalls 2.5mg Nebivolol tablets with nitrosamine impurity above safety limits. Rx-only bottles from specific lots may pose health risks.
Aurobindo PharmaDec 6, 2024 - UnratedDrug
Aurobindo Pharma USA Inc recalls Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC
Aurobindo Pharma recalls 60mg Cinacalcet tablets with N-nitroso impurity above FDA limits. Rx-only medication affected by specific lot numbers and packaging. Consumers should contact pharmacy for details.
Aurobindo PharmaNov 7, 2024 - Lower riskDrug
Aurobindo Pharma USA Inc recalls Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles,
Aurobindo Pharma recalls 100-count Healthy Living Acetaminophen, Aspirin and Caffeine tablets due to missing manufacturer label. This affects some bottles sold in the US with specific lot numbers.
Aurobindo PharmaJul 11, 2024 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle,
Aurobindo Pharma recalls 7.5mg Clorazepate Dipotassium Tablets with yellow spots. Discard affected lots to avoid potential discoloration issues.
Aurobindo PharmaApr 24, 2024 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC
Aurobindo Pharma recalls 0.5mg Rasagiline Tablets (30-count) due to failed dissolution testing. This may affect drug effectiveness. Check NDC 0378-1270-93 and lot 3112444.
Aurobindo PharmaAug 2, 2023 - UnratedDrug
Aurobindo Pharma USA Inc. recalls Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279
Aurobindo Pharma USA Inc. recalls 400mg Rufinamide Tablets (120-count) due to cGMP deviations in batch production. This recall follows release of the batch before regulatory approval. No specific action steps are listed in the official notice.
Aurobindo PharmaJul 21, 2023 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by:
Aurobindo Pharma USA Inc. recalls 500mg acetaminophen caplets with discoloration issues. Products may contain impurities affecting safety. Consumers should check lot numbers and contact the company for details.
Aurobindo PharmaMay 22, 2023 - Use cautionDrug
Aurobindo Pharma USA Inc. recalls Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA,
Aurobindo Pharma recalls specific lots of Quinapril and Hydrochlorothiazide tablets due to N-Nitroso-quinapril impurity exceeding acceptable limits.
Aurobindo PharmaOct 5, 2022 - Use cautionDrug
Aurobindo Pharma USA Inc. recalls Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for
Aurobindo Pharma recalls Cyanocobalamin Injection vials due to subpotent drug issues. Check lot numbers CCC210004 through CCC210011 for expiration dates.
Aurobindo PharmaApr 5, 2022 - Stop using nowDrug
Aurobindo Pharma USA Inc. recalls Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA,
Aurobindo Pharma recalls 0.5% moxifloxacin eye drops due to impurities that could cause eye injury. Affected lots from India, expiring June 2023. Stop using immediately.
Aurobindo PharmaJan 14, 2022 - UnratedDrug
Aurobindo Pharma USA Inc. recalls Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC
Aurobindo Pharma recalls 45mg Pioglitazone tablets with failed specifications that may be superpotent. Consumers should check NDC 57237-221-05 and batch numbers PF4520028A/B for affected products.
Aurobindo PharmaDec 29, 2021 - UnratedDrug
Aurobindo Pharma USA Inc. recalls Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279
Aurobindo Pharma USA Inc. recalls 6.25 mg Carvedilol tablets (NDC 65862-143-05) due to failed impurities and degradation specifications. This Rx-only medication was distributed from 279 Princeton-Hightstown Road, East Windsor, NJ.
Aurobindo PharmaNov 15, 2021 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279
Aurobindo Pharma recalls 100mg Metoprolol Tartrate tablets due to metal wire found in one tablet. This could cause injury if swallowed. Contact for return instructions.
Aurobindo PharmaSep 9, 2021 - UnratedDrug
Aurobindo Pharma USA Inc. recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by:
Aurobindo Pharma recalls 500-tablet sulfamethoxazole-trimethoprim (800mg/160mg) prescription medication due to potential metal contamination. This recall affects specific batches made in India with NDC 65862-420-05.
Aurobindo PharmaJul 7, 2021 - Stop using nowDrug
Aurobindo Pharma USA Inc. recalls Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279
Aurobindo Pharma recalls 1,296 bottles of Famotidine 40mg due to contamination with Famotidine 20mg and ibuprofen 400mg tablets.
Aurobindo PharmaJan 20, 2021 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 fl oz (120
Aurobindo Pharma recalls Fluent Children's Fever + Pain IBUPROFEN Oral Suspension due to missing dosing cups, which could lead to incorrect dosing for children.
Aurobindo PharmaOct 22, 2020 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only,
Aurobindo Pharma recalls 500-tablet bottles of Sulfamethoxazole and Trimethoprim Tablets (800 mg/160 mg) due to metal wire complaints. This could cause injury if swallowed. Contact for return instructions.
Aurobindo PharmaAug 10, 2020 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Clozapine Tablets USP tablet, 100mg, 500-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279
Aurobindo Pharma USA recalls 100mg Clozapine tablets (500-count) after consumer complaints of 50mg tablets being present in some bottles.
Aurobindo PharmaJun 12, 2020 - UnratedDrug
Aurobindo Pharma USA Inc. recalls Olanzapine Tablets, USP 7.5 mg, 30-count bottle, Rx only, Manufactured for: Prasco Laboratories Mason, OH 45040 USA,
Aurobindo Pharma recalls 7.5mg Olanzapine tablets due to failed impurities and degradation. Rx-only bottles with specific lot number and expiration date are affected. Consumers should contact the manufacturer for details.
Aurobindo PharmaMay 26, 2020 - UnratedDrug
Aurobindo Pharma USA Inc. recalls Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ
Aurobindo Pharma recalls 100mg gabapentin capsules due to water leakage during manufacturing. Products may pose contamination risks. Check NDC 65862-198-99 and lot numbers for affected items.
Aurobindo PharmaMar 18, 2020 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed
Aurobindo Pharma USA Inc. recalls 20mg amphetamine tablets that may be out of specification for weight and thickness. This is a prescription-only product distributed by Aurobindo Pharma USA Inc. in the US.
Aurobind: Aurobindo Pharma USA IncSep 19, 2019 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810
Aurobindo Pharma USA recalls 1000-count Simvastatin 40mg tablets due to incorrect lot and expiration dates on some bottles. Affected lots include 05318054B (exp 3/2021).
Aurobindo PharmaJul 29, 2019 - Lower riskDrug
Aurobindo Pharma USA Inc. recalls Lidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E
Aurobindo Pharma USA Inc recalls Lidocaine HCl Injection vials from India with a hair found inside. This could cause injury during medical use. Consumers should contact the manufacturer for details.
Aurobind: Aurobindo Pharma USA IncMar 28, 2019 - Use cautionDrug
Aurobindo Pharma USA Inc. recalls Valsartan Tablets USP 40 mg, 30 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC
Aurobindo Pharma recalls specific lots of Valsartan Tablets USP 40 mg due to trace amounts of the impurity NDEA found in the manufacturing process.
Aurobindo PharmaDec 31, 2018 - Stop using nowDrug
Aurobindo Pharma USA Inc. recalls Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ
Aurobindo Pharma recalls 320mg Valsartan tablets with NDEA impurity above safe levels. FDA confirmed impurity in API used for manufacturing. Stop using immediately if you have these specific lots.
Aurobindo PharmaDec 31, 2018 - UnratedDrug
Aurobindo Pharma USA Inc. recalls Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, Rx only, 30-count bottle, Distributed by: Aurobindo Pharma
Aurobindo Pharma recalls 5mg/40mg Amlodipine and Olmesartan Medoxomil tablets that were pink instead of cream. This is a pharmacist-reported discoloration issue for prescription use.
Aurobindo PharmaNov 30, 2018 - Lower riskDrug
Aurobindo Pharma USA Inc recalls Venlafaxine Hydrochloride extended release capsules, 37.5 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo
Aurobindo Pharma USA recalls 37.5 mg Venlafaxine Hydrochloride extended release capsules due to punctured or clumped capsules that could affect safety. This Rx-only product was manufactured for Aurobindo.
AurobindoDec 22, 2016 - Lower riskDrug
Aurobindo Pharma USA Inc recalls Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6
Aurobindo Pharma USA Inc recalls Pantoprazole Sodium 40mg injections with yellowish-brown powder. Discoloration may indicate contamination. Check NDC 55150-202-00 and lot CPO160028.
Aurobind: Aurobindo Pharma USA IncDec 16, 2016 - Lower riskDrug
Aurobindo Pharma USA Inc recalls Pantoprazole Sodium Delayed-Release Tablets USP, 40 mg Rx Only, 90 tablets per bottle, Manufactured for Aurobindo
Aurobindo Pharma USA recalls Pantoprazole Sodium 40mg tablets due to foreign Montelukast Sodium tablets found in some bottles. No immediate action needed but check for foreign tablets.
AurobindoAug 3, 2016 - Use cautionDrug
Aurobindo Pharma USA Inc recalls Gabapentin Capsules, USP 300 mg, 100-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141;
Northstar Rx recalls 24,816 bottles of Gabapentin 300 mg capsules due to complaints of empty capsules. Check your lot number GESB14011-A.
Northstar RxOct 17, 2014 - Use cautionDrug
Aurobindo Pharma USA Inc recalls Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400
Aurobindo Pharma recalls 1776 bottles of Lisinopril 30mg tablets due to incorrect strength labeling. Check your lot numbers for details.
Aurobindo PharmaApr 9, 2013
Aurobindo Pharma USA Inc recall questions
How many recalls has Aurobindo Pharma USA Inc had?
59 recalls from Aurobindo Pharma USA Inc are on record with U.S. safety agencies, from 2013–2026.
What is the most recent Aurobindo Pharma USA Inc recall?
Aurobindo Pharma USA Inc recalls Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279, dated Jul 23, 2026. Every Aurobindo Pharma USA Inc recall is listed on this page, newest first.
Why are Aurobindo Pharma USA Inc products recalled?
The most common reasons on record: cGMP deviations: Batch was released prior to approval. (2); Discoloration: Dotted and yellow spots on tablets (2); Failed Impurities/ Degradation Specifications (2); Failed Impurities/Degradation Specifications (2).
What should I do if I have a recalled Aurobindo Pharma USA Inc product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Aurobindo Pharma USA Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.