The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0291-2022·Announced 2021-12-29

Rompe Pecho Cough Syrup Recalled for Microbial Contamination

Efficient Laboratories, Inc. is recalling Rompe Pecho DM cough syrup (6 fl oz bottles) due to microbial contamination of the non-sterile product. The recall affects 27,206 bottles distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall. Microbial contamination of a non-sterile oral product poses a potential health risk. No reported illnesses or hospitalizations are stated in the source text, so the hazard remains theoretical, placing this at the upper end of High rather than Severe.

Plain-English summary

Efficient Laboratories, Inc. is recalling Rompe Pecho DM (Dextromethorphan HBr and Guaifenesin), a non-sterile oral cough syrup and expectorant product, due to microbial contamination. The affected product is distributed in 6 fl oz (178 mL) bottles nationwide within the United States.

Approximately 27,206 bottles have been distributed. The recall affects products with the following lot numbers and expiration dates: Lot #19F168 (Exp. June 2022), Lot #19G145 (Exp. July 2022), Lot #19G361 (Exp. July 2022), Lot #19G449 (Exp. July 2022), and Lot #19G491 (Exp. July 2022). The NDC is 58593-275-06.

Consumers who have purchased this product should stop using it immediately. Those with questions or concerns may contact Efficient Laboratories, Inc. at their Miami, FL location or the FDA through its standard recall reporting channels.

The recalled product

Product
ROMPE PECHO (DEXTROMETHORPHAN HBR, GUAIFENESIN)
Brand
ROMPE PECHO
Manufacturer
Efficient Laboratories, Inc.
Category
Drug — Over-the-Counter Cough/Cold Syrup
Hazard
Affected units
27,206

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 19F168 Exp. June 2022
  • 19G145
  • 19G361
  • 19G449 19G491 Exp. July 2022.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Efficient Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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