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& Benefits of Medications
FDA Drug Recalls and Warnings: Atorvastatin; Labeling Mix-Up with Muscle Relaxant Cyclobenzaprine, and More
Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions
October 23, 2025
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Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting recalls for Aripiprazole, Atorvastatin, Azelaic Acid Gel, Bevacizumab, Carbamazepine, Chlorpromazine, Cyclobenzaprine, Dextroamphetamine, Entecavir, Sulfamethoxazole, and Timolol Maleate Ophthalmic Eye Drops.
All of the recalls in this installment have been assigned a “Class II” level by the FDA (see below for definitions of recall types), except for Cyclobenzaprine Hydrochloride, which was designated a “Class I” level recall. The Class I recall was issued after bottles of the arthritis pain drug Meloxicam were found to be mislabeled as cyclobenzaprine hydrochloride, the generic form of the muscle relaxant Flexeril.
How to Read This Report
This report is prepared using the most recent information posted in the FDA’s Enforcement Reports Database (for recalls), Warning Letters Database (for warning letters), and Drug Imports Alerts Database (for drug importers subject to import bans). Not all new entries to the databases are included in this report. Selected entries are chosen based on the type of product and the potential safety impact of the recall or warning.
Recall announcements and warnings are simplified to improve clarity and accessibility. In some cases, additional sources such as company statements, FDA press releases, and industry publications may provide further details. The primary sources for this report include:
Recalls (Enforcement Reports Database)
The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”
While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.
- Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”
- Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.
- Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.
Warning Letters (Warning Letters Database)
Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.
Drug Imports Alerts Database
FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of FDA laws, including violations of “current good manufacturing practices for finished pharmaceuticals” or unapproved new drugs. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.
Drug Recalls
Aripiprazole Tablets (generic for Abilify)
Company: Ascend Laboratories, LLC
Manufacturing Location: Alkem Laboratories Ltd., Mumbai, India
Scope: 2,256 bottles of 30-count 10 mg tablets
Drug Purpose: Treats schizophrenia and bipolar disorder
Recall Reason: Superpotent tablets contain a higher-than-specified amount of active ingredient
Recall Initiation Date: Initiated September 24, 2025
Link: FDA Enforcement Report
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Atorvastatin Calcium Tablets (generic for Lipitor)
Company: Ascend Laboratories, LLC
Manufacturing Location: Alkem Laboratories Ltd., Mumbai, India
Scope: 141,984 10mg bottles (90, 500, and 1000-count); also 20mg, 40mg, and 80mg (90, 500, and 1000-count bottles, bottle quantity not specified)
Drug Purpose: A statin treatment for high cholesterol
Recall Reason: Failed dissolution specifications, which means there may be problems with long-term stability of the drug
Recall Initiation Date: September 10, 2025
Link: FDA Enforcement Report
Azelaic Acid Gel
Company: Glenmark Pharmaceuticals
Manufacturing Location: Colvale-Bardez, Goa, India
Scope: 13,824 tubes (15%, 50 grams)
Drug Purpose: Topical prescription treatment for acne and rosacea
Recall Reason: Market complaints of gritty, grainy texture
Recall Initiation Date: September 17, 2025
Link: FDA Enforcement Report
Bevacizumab Injection (generic for Avastin)
Company: Fagron Sterile Services
Manufacturing Location: Wichita, Kansas
Scope: 109,320 sterile single-dose syringes (1.25mg/0.05mL)
Drug Purpose: Treats lung, liver, cervical, kidney, and other cancers; often used in combination with chemotherapy
Recall Reason: Lack of assurance of sterility
Recall Initiation Date: August 29, 2025
Link: FDA Enforcement Report
Carbamazepine Extended-Release Tablets (generic for Tegretol)
Company: American Health Packaging, Columbus, OH
Manufacturing Location: Not specified
Scope: 360 cartons of 30 tablets (400 mg) per 3×10 unit dose cards
Drug Purpose: Prevents and controls seizures; sometimes used for nerve pain
Recall Reason: Failed dissolution specifications, which means there may be problems with the long-term stability of the drug
Recall Initiation Date: September 15, 2025
Link: FDA Enforcement Report
Chlorpromazine Hydrochloride Tablets (generic for Thorazine, a discontinued brand)
Company: Amneal Pharmaceuticals
Manufacturing Location: Ahmedabad, India
Scope: Over 35,000 100-count bottles of various strengths (25 mg, 50 mg, 100 mg, and 200 mg)
Drug Purpose: Treats schizophrenia and other mood disorders
Recall Reason: Presence of microorganism on packaging coil; no contamination was found on tablets
Recall Initiation Date: August 18, 2025
Link: FDA Enforcement Report
Cyclobenzaprine Hydrochloride Tablets (generic for Flexeril and Amrix)
Company: Unichem Pharmaceuticals (USA), Inc.
Manufacturing Location: Bardez, Goa, India
Scope: 230 90-count bottles of 10 mg tablets
Drug Purpose: Muscle relaxant used to treat spasms
Recall Reason: Labeling mix-up; Bottles containing Meloxicam 7.5 mg tablets were mislabeled as Cyclobenzaprine; Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) used to treat arthritis pain
Essential Extras: This is a Class I recall, the most urgent kind of recall because of potential danger to consumers. The lot number is GMML24026A with a product expiration of 09/30/2027. As of August 27, Unichem had not received any reports of adverse events related to the recall.
Risk Statement: Unichem warns that for patients who unknowingly take Meloxicam, there is a reasonable probability of serious adverse events, including cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions, particularly in those patients also taking non-steroidal anti-Inflammatory drugs (NSAIDs) and/or blood thinners, those who have allergies to Meloxicam, or those with underlying illnesses. Recall Initiation Date: August 27, 2025
Link: FDA Press Release and FDA Enforcement Report
Dextroamphetamine Sulfate Tablets (generic for Dexedrine)
Company: Lannett Company, Inc.
Manufacturing Location: Not specified
Scope: 4,800 100-count bottles of 10 mg tablets
Drug Purpose: Treats Attention Deficit Hyperactivity Disorder (ADHD)
Recall Reason: Mix-up; one 5 mg tablet found in two 10 mg bottles
Recall Initiation Date: July 2025
Link: FDA Enforcement Report
Entecavir Tablets (generic for Baraclude)
Company: Zydus Lifesciences Ltd.
Manufacturing Location: Ahmedabad, India
Scope: 4,344 30-count bottles of .5 mg tablets; 4,440 30-count bottles of 1 mg tablets
Drug Purpose: Treats liver infection caused by hepatitis B
Recall Reason: Failed impurity test; failed degradation test, which could affect shelf-life
Recall Initiation Date: September 4, 2025
Link: FDA Enforcement Report
Sulfamethoxazole and trimethoprim (generic for Bactrim)
Company: Amneal Pharmaceuticals
Manufacturing Location: Ahmedabad, India
Scope: 140,000 100-count and 500-count bottles of double-strength tablets
Drug Purpose: Sulfa-type antibiotic treats a variety of bacterial infections
Recall Reason: Presence of microorganism on packaging coil; no contamination was found on tablets
Recall Initiation Date: August 18, 2025
Link: FDA Enforcement Report
Timolol Maleate Ophthalmic Eye Drops
Company: FDC Limited (distributed by Rising Sun Pharmaceuticals and Apotex)
Manufacturing Location: Aurangabad, Maharashtra, India
Scope: 154,176 bottles of 0.5% (5 mL) and 60,428 bottles of .5% (10 mL)
Drug Purpose: Treats glaucoma and ocular hypertension (high pressure inside the eye)
Recall Reason: Defective cap and container; spike of the cap may block nozzle
Recall Initiation Date: April 18 2025 (10mL bottles) and July 5, 2025 (5mL bottles)
Link: FDA Enforcement Report for 10ml bottles and FDA Enforcement Report for 5mL bottles
- Enforcement report. (n.d.). FDA
- Office of the Commissioner. (2025, October 21). Warning letters. U.S. Food And Drug Administration.
- Investigations, O. O. I. A. (2025, March 3). Import alerts. U.S. Food And Drug Administration.
- 21 CFR Part 211 — Current good manufacturing practice for finished Pharmaceuticals. (n.d.).
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<p>Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions. In this installment, we’re highlighting recalls for Aripiprazole, Atorvastatin, Azelaic Acid Gel, Bevacizumab, Carbamazepine, Chlorpromazine, Cyclobenzaprine, Dextroamphetamine, Entecavir, Sulfamethoxazole, and Timolol Maleate Ophthalmic Eye Drops.</p>
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<p>All of the recalls in this installment have been assigned a “Class II” level by the FDA (see below for definitions of recall types), except for Cyclobenzaprine Hydrochloride, which was designated a “Class I” level recall. The Class I recall was issued after bottles of the arthritis pain drug Meloxicam were found to be mislabeled as cyclobenzaprine hydrochloride, the generic form of the muscle relaxant Flexeril.</p>
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<p>This report is prepared using the most recent information posted in the<a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm" target="_blank" rel="noreferrer noopener"> FDA’s Enforcement Reports Database</a> (for recalls), <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters" target="_blank" rel="noreferrer noopener">Warning Letters Database</a> (for warning letters), and<a href="https://www.fda.gov/industry/actions-enforcement/import-alerts" target="_blank" rel="noreferrer noopener"> Drug Imports Alerts Database</a> (for drug importers subject to import bans). Not all new entries to the databases are included in this report. Selected entries are chosen based on the type of product and the potential safety impact of the recall or warning.</p>
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<p>Recall announcements and warnings are simplified to improve clarity and accessibility. In some cases, additional sources such as company statements, FDA press releases, and industry publications may provide further details. The primary sources for this report include:</p>
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<h3 class="wp-block-heading">Recalls (Enforcement Reports Database)</h3>
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<p>The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”</p>
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<p>While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.</p>
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<li>Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”</li>
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<li>Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.</li>
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<li>Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.</li>
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<h3 class="wp-block-heading">Warning Letters (Warning Letters Database)</h3>
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<p>Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.</p>
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<h3 class="wp-block-heading">Drug Imports Alerts Database</h3>
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<p>FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211" target="_blank" rel="noreferrer noopener">FDA laws</a>, including violations of “current good manufacturing practices for finished pharmaceuticals” or <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-99" target="_blank" rel="noreferrer noopener">unapproved new drugs</a>. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.</p>
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<h2 class="wp-block-heading">Drug Recalls</h2>
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<h3 class="wp-block-heading">Aripiprazole Tablets (generic for Abilify)</h3>
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<p><strong>Company</strong>: Ascend Laboratories, LLC<br><strong>Manufacturing Location</strong>: Alkem Laboratories Ltd., Mumbai, India<br><strong>Scope</strong>: 2,256 bottles of 30-count 10 mg tablets<br><strong>Drug Purpose</strong>: Treats schizophrenia and bipolar disorder<br><strong>Recall Reason</strong>: Superpotent tablets contain a higher-than-specified amount of active ingredient<br><strong>Recall Initiation Date</strong>: Initiated September 24, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97511" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Atorvastatin Calcium Tablets (generic for Lipitor)</h3>
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<p><strong>Company</strong>: Ascend Laboratories, LLC<br><strong>Manufacturing Location</strong>: Alkem Laboratories Ltd., Mumbai, India<br><strong>Scope</strong>: 141,984 10mg bottles (90, 500, and 1000-count); also 20mg, 40mg, and 80mg (90, 500, and 1000-count bottles, bottle quantity not specified)<br><strong>Drug Purpose</strong>: A statin treatment for high cholesterol<br><strong>Recall Reason</strong>: Failed dissolution specifications, which means there may be problems with long-term stability of the drug<br><strong>Recall Initiation Date</strong>: September 10, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97639" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Azelaic Acid Gel</h3>
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<p><strong>Company</strong>: Glenmark Pharmaceuticals<br><strong>Manufacturing Location</strong>: Colvale-Bardez, Goa, India<br><strong>Scope</strong>: 13,824 tubes (15%, 50 grams)<br><strong>Drug Purpose</strong>: Topical prescription treatment for acne and rosacea<br><strong>Recall Reason</strong>: Market complaints of gritty, grainy texture<br><strong>Recall Initiation Date</strong>: September 17, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97619" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Bevacizumab Injection (generic for Avastin)</h3>
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<p><strong>Company</strong>: Fagron Sterile Services<br><strong>Manufacturing Location</strong>: Wichita, Kansas<br><strong>Scope</strong>: 109,320 sterile single-dose syringes (1.25mg/0.05mL)<br><strong>Drug Purpose</strong>: Treats lung, liver, cervical, kidney, and other cancers; often used in combination with chemotherapy<br><strong>Recall Reason</strong>: Lack of assurance of sterility<br><strong>Recall Initiation Date:</strong> August 29, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Product=215890" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Carbamazepine Extended-Release Tablets (generic for Tegretol)</h3>
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<p><strong>Company</strong>: American Health Packaging, Columbus, OH<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 360 cartons of 30 tablets (400 mg) per 3×10 unit dose cards<br><strong>Drug Purpose</strong>: Prevents and controls seizures; sometimes used for nerve pain<br><strong>Recall Reason</strong>: Failed dissolution specifications, which means there may be problems with the long-term stability of the drug<br><strong>Recall Initiation Date</strong>: September 15, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97634" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Chlorpromazine Hydrochloride Tablets (generic for Thorazine, a discontinued brand)</h3>
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<p><strong>Company</strong>: Amneal Pharmaceuticals<br><strong>Manufacturing Location</strong>: Ahmedabad, India<br><strong>Scope</strong>: Over 35,000 100-count bottles of various strengths (25 mg, 50 mg, 100 mg, and 200 mg)<br><strong>Drug Purpose</strong>: Treats schizophrenia and other mood disorders<br><strong>Recall Reason</strong>: Presence of microorganism on packaging coil; no contamination was found on tablets<br><strong>Recall Initiation Date</strong>: August 18, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=97438" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Cyclobenzaprine Hydrochloride Tablets (generic for Flexeril and Amrix)</h3>
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<p><strong>Company</strong>: Unichem Pharmaceuticals (USA), Inc.<br><strong>Manufacturing Location</strong>: Bardez, Goa, India<br><strong>Scope</strong>: 230 90-count bottles of 10 mg tablets<br><strong>Drug Purpose</strong>: Muscle relaxant used to treat spasms<br><strong>Recall Reason</strong>: Labeling mix-up; Bottles containing Meloxicam 7.5 mg tablets were mislabeled as Cyclobenzaprine; Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) used to treat arthritis pain<br><strong>Essential Extras</strong>: This is a Class I recall, the most urgent kind of recall because of potential danger to consumers. The lot number is GMML24026A with a product expiration of 09/30/2027. As of August 27, Unichem had not received any reports of adverse events related to the recall.<br><strong>Risk Statement</strong>: Unichem warns that for patients who unknowingly take Meloxicam, there is a reasonable probability of serious adverse events, including cardiovascular, gastrointestinal, renal, anaphylaxis, and skin reactions, particularly in those patients also taking non-steroidal anti-Inflammatory drugs (NSAIDs) and/or blood thinners, those who have allergies to Meloxicam, or those with underlying illnesses. Recall Initiation Date: August 27, 2025<br><strong>Link</strong>: <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unichem-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-cyclobenzaprine-hydrochloride" target="_blank" rel="noreferrer noopener">FDA Press Release</a> and <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97482" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Dextroamphetamine Sulfate Tablets (generic for Dexedrine)</h3>
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<p><strong>Company</strong>: Lannett Company, Inc.<br><strong>Manufacturing Location</strong>: Not specified<br><strong>Scope</strong>: 4,800 100-count bottles of 10 mg tablets<br><strong>Drug Purpose</strong>: Treats Attention Deficit Hyperactivity Disorder (ADHD)<br><strong>Recall Reason:</strong> Mix-up; one 5 mg tablet found in two 10 mg bottles<br><strong>Recall Initiation Date</strong>: July 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=215642" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Entecavir Tablets (generic for Baraclude)</h3>
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<p><strong>Company</strong>: Zydus Lifesciences Ltd.<br><strong>Manufacturing Location</strong>: Ahmedabad, India<br><strong>Scope</strong>: 4,344 30-count bottles of .5 mg tablets; 4,440 30-count bottles of 1 mg tablets<br><strong>Drug Purpose</strong>: Treats liver infection caused by hepatitis B<br><strong>Recall Reason</strong>: Failed impurity test; failed degradation test, which could affect shelf-life<br><strong>Recall Initiation Date</strong>: September 4, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97556" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Sulfamethoxazole and trimethoprim (generic for Bactrim)</h3>
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<p><strong>Company</strong>: Amneal Pharmaceuticals<br><strong>Manufacturing Location</strong>: Ahmedabad, India<br><strong>Scope</strong>: 140,000 100-count and 500-count bottles of double-strength tablets<br><strong>Drug Purpose</strong>: Sulfa-type antibiotic treats a variety of bacterial infections<br><strong>Recall Reason:</strong> Presence of microorganism on packaging coil; no contamination was found on tablets<br><strong>Recall Initiation Date</strong>: August 18, 2025<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/?Event=97438" target="_blank" rel="noreferrer noopener">FDA Enforcement Report</a></p>
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<h3 class="wp-block-heading">Timolol Maleate Ophthalmic Eye Drops</h3>
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<p><strong>Company</strong>: FDC Limited (distributed by Rising Sun Pharmaceuticals and Apotex)<br><strong>Manufacturing Location</strong>: Aurangabad, Maharashtra, India<br><strong>Scope</strong>: 154,176 bottles of 0.5% (5 mL) and 60,428 bottles of .5% (10 mL)<br><strong>Drug Purpose</strong>: Treats glaucoma and ocular hypertension (high pressure inside the eye)<br><strong>Recall Reason</strong>: Defective cap and container; spike of the cap may block nozzle<br><strong>Recall Initiation Date</strong>: April 18 2025 (10mL bottles) and July 5, 2025 (5mL bottles)<br><strong>Link</strong>: <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=96740" target="_blank" rel="noreferrer noopener">FDA Enforcement Report for 10ml bottles</a> and <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=97219" target="_blank" rel="noreferrer noopener">FDA Enforcement Report for 5mL bottles</a></p>
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