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Browse Drug Recalls

8 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 8 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 8 FDA drug recalls.

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DateProductReasonClassFirm
Aug 24, 2021 Rompe Pecho DM, 6 Fl Oz (178 mL) bottles, Distributed by: Efficient Laborator... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 24, 2021 Rompe Pecho CF Cold & Flu Advanced Formula, 6 Fl. oz. (178 mL) bottles, Dist... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 24, 2021 Rompe Pecho Ex Expectorant, packaged in a) 4 Fl. Oz. (118 mL) bottles NDC 58... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 24, 2021 Rompe Pecho Max Multi-Symptoms Maximum Strength, 8 Fl. Oz. (237 mL) bottles, ... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Jan 31, 2020 Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed b... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Jan 31, 2020 Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Effici... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Jan 31, 2020 New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by... Microbial Contamination of Non-Sterile Products Class II Efficient Laboratories, Inc.
Aug 3, 2018 Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distribu... CGMP Deviations: products manufactured under conditions that could impact its product quality. Class II Product Quest Manufacturing LLC

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.