chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: A...

FDA Drug Recall #D-0618-2025 — Class II — August 18, 2025

Recall Summary

Recall Number D-0618-2025
Classification Class II — Moderate risk
Date Initiated August 18, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Amneal Pharmaceuticals, LLC
Location Bridgewater, NJ
Product Type Drugs
Quantity 14,923 100-count bottles

Product Description

chlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1060-1.

Reason for Recall

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.

Distribution Pattern

Distributed Nationwide in the USA

Lot / Code Information

Lot: AM240334, AM240335, Exp Date 02/28/2027, AM241031, Exp Date 06/30/2027.

Other Recalls from Amneal Pharmaceuticals, LLC

Recall # Classification Product Date
D-0619-2025 Class II chlorproMAZINE Hydrochloride Tablets, USP, 200 ... Aug 18, 2025
D-0616-2025 Class II chlorproMAZINE Hydrochloride Tablets, USP, 25 m... Aug 18, 2025
D-0615-2025 Class II Sulfamethoxazole and Trimethoprim Tablets, USP ... Aug 18, 2025
D-0617-2025 Class II chlorproMAZINE Hydrochloride Tablets, USP, 50 m... Aug 18, 2025
D-0488-2025 Class I Sulfamethoxazole and Trimethoprim Tablets, USP,... Jun 2, 2025

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.