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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Pfizer Inc.: Zoloft and Diphenoxylate/Atropine Recalled for Incorrect Tablet Potency

Agency Publication Date: January 4, 2018
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Summary

Pfizer is recalling approximately 185,409 bottles of Zoloft (sertraline HCl) and Diphenoxylate Hydrochloride/Atropine Sulfate tablets due to weight variations that may cause the medication to be too strong or too weak. This recall affects 100-count and 1,000-count bottles of Diphenoxylate/Atropine and 30-count bottles of Zoloft 25 mg tablets distributed nationwide. Because the dosage in these tablets may not be accurate, consumers should immediately contact their healthcare provider or pharmacist for guidance on how to manage their medication regimen.

Risk

Variations in tablet weight can lead to 'sub-potent' or 'super-potent' doses, meaning patients may receive significantly less or more medication than prescribed. Receiving an incorrect dose of these medications can lead to a loss of symptom control or an increased risk of serious side effects and toxicity.

What You Should Do

  1. Check your prescription bottles for Diphenoxylate Hydrochloride and Atropine Sulfate Tablets (2.5 mg/0.025 mg) with NDC 59762-1061-1 (100-count) or NDC 59762-1061-2 (1,000-count) and Lot numbers R83962, R93347, R93348, R93349, R93350, R93351, R93352 (Exp. 2021 OCT 31); S57831, S57832, S57834 (Exp. 2021 NOV 30); or R93356, R93357, R93358, R97310 (Exp. 2021 OCT 31).
  2. Check your prescription bottles for Zoloft (sertraline HCl) 25 mg tablets (30-count) with NDC 0049-4960-30 and Lot number S84026.
  3. If your medication is part of this recall, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a replacement prescription.
  4. Return any unused or affected medication to the pharmacy where you purchased it for a refund.
  5. Contact Pfizer Inc. at their New York headquarters or the distributor (Greenstone LLC or Roerig Division of Pfizer) for further instructions regarding the return process.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg (100-count bottle)
Model:
NDC 59762-1061-1
D-0150-2018
Lot Numbers:
R83962 (Exp. 2021 OCT 31)
R93347 (Exp. 2021 OCT 31)
R93348 (Exp. 2021 OCT 31)
R93349 (Exp. 2021 OCT 31)
R93350 (Exp. 2021 OCT 31)
R93351 (Exp. 2021 OCT 31)
R93352 (Exp. 2021 OCT 31)
S57831 (Exp. 2021 NOV 30)
S57832 (Exp. 2021 NOV 30)
S57834 (Exp. 2021 NOV 30)
Date Ranges: 2021 OCT 31, 2021 NOV 30
Product: diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg (1000-count bottle)
Model:
NDC 59762-1061-2
D-0150-2018
Lot Numbers:
R93356 (Exp. 2021 OCT 31)
R93357 (Exp. 2021 OCT 31)
R93358 (Exp. 2021 OCT 31)
R97310 (Exp. 2021 OCT 31)
Date Ranges: 2021 OCT 31
Product: Zoloft (sertraline HCl) tablets 25 mg (30-count bottle)
Model:
NDC 0049-4960-30
D-0151-2018
Lot Numbers:
S84026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78332
Status: Resolved
Manufacturer: Pfizer Inc.
Sold By: Greenstone LLC; Roerig Division of Pfizer Inc.; Pharmacies
Manufactured In: United States
Units Affected: 2 products (183437 bottles; 1972 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.